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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGIWRAP

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SURGIWRAP   Back to Search Results
Event Date 11/07/2006
Event Type  Injury   Patient Outcome  Hospitalization
Event Description

Pt had laparoscopic hysterectomy 2006. Surgiwrap was placed to prevent adhesions. This eroded into the vagina and lacerated her partner. This was removed at exploratory lap five months later.

 
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Type of DeviceSURGIWRAP
Device Event Key1441934
MDR Report Key1379626
Event Key2964896
Report NumberMW5011055
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 11/09/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2006
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

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