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

Catalog Number PHY2025V

Device Problems Reaction (1514); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Inflammation (1932); Hernia (2240); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that a patient underwent a laparoscopic hernia repair procedure on (b)(6) 2012 and mesh was used. Twenty days post operatively, the patient experienced severe inflammation due to the foreign body mesh and developed an recurrent incisional hernia. The patient underwent a reoperation on (b)(6) 2012. During the reoperation, adhesions were found and the mesh was covered with a thick and whitish rind, which could be the neoperitoneum, with white bubbles, also present on the colon, as further evidence of excessive inflammatory reaction developed by the patient. The mesh was completely and easily removed because it was not integrated at all. A different type of mesh was used to repair the hernia. Currently, the patient is getting better.

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). Conclusion: a photo of the actual explanted mesh device was evaluated. There was a lack of tissue incorporation in the mesh. The mechanism for the underlying the early separation of the mesh could not be determined.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL
• 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: 2639885
• MDR Text Key: 2824634
• Report Number: 2210968-2012-02567
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: IT
• 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: 06/15/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/05/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: PHY2025V
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/25/2012
• 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: 07/05/2012 Patient Sequence Number: 1