• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGIWRAP

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

SURGIWRAP Back to Search Results
Event Date 11/07/2006
Event Type  Injury  
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.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceSURGIWRAP
MDR Report Key1379626
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

Date Received: 11/16/2006 Patient Sequence Number: 1