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

Catalog Number PHY1015V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hernia (2240); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: device lot number? - sales rep.Reported ni, lot number is not available.Specific type of hernia repair (i.E.Ventral, umbilical and laparoscopic or open)? -sales rep.Reported ni.Was there difficulty with the purple suture or did the surgeon associate the reported difficulty with the mesh only? - sales rep.Reported the complaint was specifically related to the mesh, no difficulty with sutures.It was reported that the mesh was removed, it is available for return/evaluation?- sales rep.Reported not available for return, the mesh was removed but not retained for return/evaluation.Rep.Reported mesh with tissue was discarded.

Event Description

It was reported that the patient underwent a hernia repair procedure on (b)(6) 2014 and the mesh was implanted.On (b)(6) 2016 , the patient underwent a re-operation and mesh was removed and replaced with other product.It was also reported that the initial mesh shrank from the original size and the hernia grew through the mesh back into the original hernia spot.

• Brand Name: PHYSIOMESH OVAL
• 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: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5866762
• MDR Text Key: 51812443
• Report Number: 2210968-2016-11247
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHY1015V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention