Catalog Number UNK STRATTICE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Seroma (2069)
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Event Date 06/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been returned.Based on the information reported, including no identification of the relevant lot number, a relationship between the event and strattice cannot be determined.Strattice as a contributing factor cannot be ruled out.Multiple attempts were made to gather additional information; however to date, no further information has been obtained.The device was not returned for evaluation and the lot number remains unknown; therefore internal investigation into the event could not be performed.If additional information is reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.
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Event Description
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It was reported that the patient under nipple-sparing skin-sparing mastectomy, implant and strattice based reconstruction on (b)(6) 2018.This was complicated by moderate amount of perimplant hematoma and seroma that was treated conservatively with serial ultrasound-guided drainage.The situation did not resolve; therefore, there was exploration of the reconstruction, which was performed on friday(b)(6) 2019.The approach was through the site of the previous incision on the inframammary fold where the implant was found to be ruptured.There was the old hematoma and some perimplant seroma as well.Almost all of the strattice was taken, and there was no active bleeding or signs of infection.
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Event Description
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It was reported that the patient under nipple-sparing skin-sparing mastectomy, implant and strattice based reconstruction on (b)(6) 2018.This was complicated by moderate amount of perimplant hematoma and seroma that was treated conservatively with serial ultrasound-guided drainage.The situation did not resolve; therefore, there was exploration of the reconstruction, which was performed on friday (b)(6) 2019.The approach was through the site of the previous incision on the inframammary fold where the implant was found to be ruptured.There was the old hematoma and some perimplant seroma as well.Almost all of the strattice was taken, and there was no active bleeding or signs of infection.The strattice remains implanted.
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Manufacturer Narrative
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Follow up with explanting surgeon confirmed that the strattice was not removed.The strattice was fully taken with no loose bits.The strattice will not be returned as it remains implanted.
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Search Alerts/Recalls
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