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At approximately 1:00 PM September 17, 200 … At approximately 1:00 PM September 17, 2003 the Agency was informed of a medical event. The reporting individual indicated that in the course of treating a breast cancer, a saline filled balloon was used to aid in positioning the HDR source, Iridium 192, approximately 9.589 curies. Starting September 15, 2003, a series of 10 fractional treatments was prescribed. Between each, an ultra sound image was made to assure the continued proper placement of the source. The ultra sound technician indicated all was ok for all treatments. After the series was completed, the balloon was deflated for removal and the physician then noted that the balloon had ruptured. A review of the retained ultra sound images indicated (that) starting with treatment 7 the balloon was deflated. The doses were recalculated and the tissue dose was 40 (percent) higher than prescribed. The adjacent skin dose was calculated to be 266 cGy (centigray) rather than the 175 cGy (centigray) as originally calculated. The licensee has proposed corrective measures to prevent a recurrence of this event. The balloon manufacturer has been informed of this event.</br>The patient has been informed of the event. The medical review indicates some additional fat necrosis and possible inflammation may occur. It will be reviewed as a part of the patient follow up.viewed as a part of the patient follow up. +
20:00:00, 17 September 2003 +
13:00:00, 19 September 2003 +
20:00:00, 17 September 2003 +
At approximately 1:00 PM September 17, 200 … At approximately 1:00 PM September 17, 2003 the Agency was informed of a medical event. The reporting individual indicated that in the course of treating a breast cancer, a saline filled balloon was used to aid in positioning the HDR source, Iridium 192, approximately 9.589 curies. Starting September 15, 2003, a series of 10 fractional treatments was prescribed. Between each, an ultra sound image was made to assure the continued proper placement of the source. The ultra sound technician indicated all was ok for all treatments. After the series was completed, the balloon was deflated for removal and the physician then noted that the balloon had ruptured. A review of the retained ultra sound images indicated (that) starting with treatment 7 the balloon was deflated. The doses were recalculated and the tissue dose was 40 (percent) higher than prescribed. The adjacent skin dose was calculated to be 266 cGy (centigray) rather than the 175 cGy (centigray) as originally calculated. The licensee has proposed corrective measures to prevent a recurrence of this event. The balloon manufacturer has been informed of this event.</br>The patient has been informed of the event. The medical review indicates some additional fat necrosis and possible inflammation may occur. It will be reviewed as a part of the patient follow up.viewed as a part of the patient follow up. +
Has query"Has query" is a predefined property that represents meta information (in form of a <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Subobject">subobject</a>) about individual queries and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
00:00:00, 19 September 2003 +
AZ-07-161 +
Modification date"Modification date" is a predefined property that corresponds to the date of the last modification of a subject and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
23:43:15, 24 November 2018 +
13:00:00, 19 September 2003 +
1.708 d (41 hours, 0.244 weeks, 0.0562 months) +
20:00:00, 17 September 2003 +
URL"URL" is a <a href="/Special:Types/URL" title="Special:Types/URL">type</a> and predefined property provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a> to represent URI/URL values.