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

Catalog Number PHY1515Q

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 hernia repair procedure on an unknown date and mesh was used. The patient experienced a recurrent hernia. The reoperation took place on (b)(6) 2012. During the procedure it was noted that the mesh was found pushed together approximately one centimeter away from the hernial orifice. Additional information has been requested.

Manufacturer Narrative

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

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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 Key: 2704678
• MDR Text Key: 2801250
• Report Number: 2210968-2012-04170
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: GM
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User facility,Company Representative

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/23/2012

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 08/17/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: PHY1515Q
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/23/2012
• 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