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

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.

• Brand Name: 19.6 X 24.6 COMPOSIX KUGEL HERNIA PATCH
• Type of Device: 19.6 X 24.6 COMPOSIX KUGEL HERNIA PATCH
• Manufacturer (Section D): DAVOL, INC.
• MDR Report Key: 6198501
• MDR Text Key: 63211865
• Report Number: MW5066856
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/20/2016
• 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