MAUDE Adverse Event Report: ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC

Catalog Number PHY1520V

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Hernia (2240); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that a patient underwent a laparoscopic surgical procedure on (b)(6) 2010 to repair a ventral hernia and mesh was implanted. The patient experienced a recurrent hernia on an unknown date. The patient underwent an open hernia repair procedure (b)(6) 2011. During the procedure, the mesh was very easily removed because it was hardly attached to the peritoneum with almost no ingrowth. A different mesh was used complete the repair procedure.

Manufacturer Narrative

(b)(4). Recurrent hernia. Conclusion: the product upon which this medwatch is based is anticipated. Once the product is received, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Manufacturer Narrative

(b)(4). Results: the explanted mesh showed the non-resorbable, large pore, monofilament polypropylene mesh which shows minimal foreign body reaction. The immunohistochemical detection of the peritoneum on both the visceral and parietal side of mesh indicates that the mesh has not been placed flat against the abdominal wall. A relation to the used fixation (absorbatacks) cannot be drawn. Conclusion- the recurrence seems to be due to inadequate fixation as in the histological examination peritoneum cells were found on both sides of the mesh.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON; 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 Key: 2070827
• MDR Text Key: 1853769
• Report Number: 2210968-2011-00517
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: SW
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• 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: 04/04/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/27/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: PHY1520V
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/25/2011
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Manufacturer Received: 05/25/2011
• Was Device Evaluated By Manufacturer?: Yes
• 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: 04/27/2011 Patient Sequence Number: 1

Treatment

ABSORBATACK