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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL, INC. 19.6 X 24.6 COMPOSIX KUGEL HERNIA PATCH

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DAVOL, INC. 19.6 X 24.6 COMPOSIX KUGEL HERNIA PATCH Back to Search Results
Device Problem Contamination (1120)
Patient Problem Post Operative Wound Infection (2446)
Event Date 01/15/2015
Event Type  Injury  
Event Description
I developed an infection in my stomach area right at the area that the mesh was placed to correct my hernia. The infection became an open wound that required packing for months. I remained infected for roughly a year, until the mesh was removed.
 
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Brand Name19.6 X 24.6 COMPOSIX KUGEL HERNIA PATCH
Type of Device19.6 X 24.6 COMPOSIX KUGEL HERNIA PATCH
Manufacturer (Section D)
DAVOL, INC.
MDR Report Key6198501
MDR Text Key63211865
Report NumberMW5066856
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/20/2016 Patient Sequence Number: 1
Treatment
HERNIA PATCH; HYDROCODINE; LISINOPRIL; OMEPRAZOLE
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