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

Catalog Number PHY0715R

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

Patient Problems Unspecified Infection (1930); Pain (1994); Surgical procedure (2357)

Event Date 05/20/2011

Event Type  Injury  

Event Description

It was reported that a patient underwent an open ventral/incisional hernia repair procedure on (b)(6) 2011 and mesh was used. On (b)(6) 2011, the patient presented with abdominal pain and a high white blood cell count. The patient developed an intrabdominal infection that was (b)(6). The patient underwent reoperation on (b)(6) 2011 and seroplueralant fluid on the visceral side and parietal side of mesh was observed. The mesh was explanted. Currently, the patient is intubated in icu with sepsis. The surgeon opines the cause of the patient and (b)(6) event was renal failure at time of reported symptoms on (b)(6) 2011.

Manufacturer Narrative

(b)(4). No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).

• 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: 2127446
• MDR Text Key: 2019725
• Report Number: 2210968-2011-00780
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/25/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/15/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 09/30/2011
• Device Catalogue Number: PHY0715R
• Device LOT Number: CK9DTHZ0
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Distributor Facility Aware Date: 05/20/2011
• Device Age: 6 mo
• Event Location: Other
• Date Manufacturer Received: 06/16/2011
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 10/06/2010
• 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: 06/15/2011 Patient Sequence Number: 1