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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC PHYSIOMESH MESH, SURGICAL, POLYMERCI
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ETHICON, INC PHYSIOMESH MESH, SURGICAL, POLYMERCI Back to Search Results
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problems Adhesion(s) (1695); Pain (1994); Surgical procedure (2357)
Event Type  Injury  
Event Description

It was reported that a patient underwent a laparoscopic ipom hernia repair procedure on an unknown date and mesh was used. Approximately four to six weeks post operative, the patient complained of pain. Approximately six months after the initial procedure, the patient underwent a reoperation. It was noted that the mesh did not have complete ingrowth. Also, the bowel was adhered between the mesh and abdominal wall.

 
Manufacturer Narrative

(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

 
Manufacturer Narrative

(b)(4). Additional information: narrative - it was reported that a patient underwent a laparoscopic ipom hernia repair procedure on an unknown date and mesh was used. Approximately four to six weeks post operative, the patient complained of pain. The patient underwent a reoperation on (b)(4) 2012. It was noted that the mesh did not have complete ingrowth. Also, the bowel was adhered between the mesh and abdominal wall.

 
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Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL, POLYMERCI
Manufacturer (Section D)
ETHICON, INC
route 22 west
po box 151
somerville NJ 08876
Manufacturer (Section G)
ETHICON GMBH & COMPANY KG
robert - koch - strasse 1
po box 1409
d-22851 norderstedt NI
GM NI
Manufacturer Contact
daniel lamont
route 22 west
po box 151
somerville, NJ 08876
9082182708
MDR Report Key2799300
MDR Text Key3086392
Report Number2210968-2012-06743
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/28/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/26/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/22/2012 Patient Sequence Number: 1
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