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

Catalog Number PHY3035R

Device Problems Failure To Adhere Or Bond (1031); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Seroma (2069)

Event Type  Death  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and mesh was implanted.Following the procedure, the mesh was not integrated with the tissue allowing the development of persistent seroma.It was also reported that the patient died.Additional information has been requested.

Manufacturer Narrative

It was reported that the patient underwent a hernia ventral repair procedure on unknown date and mesh was implanted.

• Brand Name: PHYSIOMESH RECTANGULAR
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5258164
• MDR Text Key: 32412355
• Report Number: 2210968-2015-19359
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: PHY3035R
• Device Lot Number: HA8JLQB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention