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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. PHYSIOMESH MESH, SURGICAL

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ETHICON, INC. PHYSIOMESH MESH, SURGICAL Back to Search Results
Catalog Number PHY1520R
Device Problem Tears, rips, holes in device, device material
Event Date 11/08/2010
Event Type  Injury  
Event Description

It was reported that a pt underwent a primary incisional anterior abdominal wall hernia repair procedure on (b)(6) 2010 and mesh was placed using intraperitoneal onlay mesh technique. The pt developed severe pain with a visible recurrence and bulging. The pt underwent a second laparoscopic procedure on (b)(6) 2010. The surgeon discovered that the mesh came loose partially. The mesh was frayed especially where the tackers were placed. Minimal adhesion were removed and the mesh was removed. The surgeon used tension technique to close.

 
Manufacturer Narrative

(b)(4): conclusion: the product upon which this medwatch is based is anticipated. Once the product is received, any further info derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. This is one of two medwatches submitted for this device. See also medwatch 2210968-2010-01669. The same device is represented in each medwatch as it was involved in two events.

 
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Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON, INC.
somerville NJ 08876 015
Manufacturer (Section G)
ETHICON GMBH & CO KG
po box 1409
norderstedt D-22 851
GERMANY D-22851
Manufacturer Contact
daniel lamont
route 22 west
p.o. box 151
somerville , NJ 08876-0151
9082182708
MDR Report Key1929764
Report Number2210968-2010-01668
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/31/2011
Device Catalogue NumberPHY1520R
Device LOT NumberCJ9KDGZ0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/08/2010
Device Age2 mo
Event Location Other
Date Manufacturer Received11/08/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/14/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/09/2010 Patient Sequence Number: 1
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