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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAST BIOSURGERY SURGIWRAP SURGIWRAP, 130X200X0.02MM

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MAST BIOSURGERY SURGIWRAP SURGIWRAP, 130X200X0.02MM Back to Search Results
Lot Number 50963
Event Date 12/18/2009
Event Type  Injury  
Event Description

Pt had a robot assisted laparoscopic hysterectomy on (b) (6) 2009. Surgiwrap was used during the procedure as an adhesion barrier. The surwrap is now gritty and fibrous, and has started breaking off and coming out through her vagina. Dates of use: (b) (6) 2009 - (b) (6) 2010. Diagnosis or reason for use: adhesion barrier for hysterectomy.

 
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Brand NameSURGIWRAP
Type of DeviceSURGIWRAP, 130X200X0.02MM
Manufacturer (Section D)
MAST BIOSURGERY
MDR Report Key1652399
Report NumberMW5015426
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/01/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device LOT Number50963
OTHER Device ID NumberREF 27204-01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 04/01/2010 Patient Sequence Number: 1
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