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

Lot Number	UNKNOWN
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Erosion (1750); Cellulitis (1768); Fistula (1862); Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts are being made to obtain information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.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.
Event or Problem Description
It was reported that a randomized trial was completed to compare main fixation devices in regard to pain and recurrence in laparoscopic ventral incisional hernia repair (lvihr) and mesh was implanted.It was reported that the patients experienced post-operative pain, seroma, hematoma, trocar hernia, cellulitis, hernia recurrence and mesh migration into the small bowel.As a result of the mesh migration, the patient was readmitted to the hospital with an enterocutaneous fistula.The patient was treated with mesh extraction and segmental small bowel resection in the po third month.Additional information has been requested.

• Brand Name: PHYSIOMESH
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 5782201
• Report Number: 2210968-2016-10291
• Device Sequence Number: 593994
• Product Code: FTL
• Combination Product (Y/N): N
• PMA/510(K) Number: K093932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Type of Report: Initial
• Report Date (Section B): 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2016
• Initial Report FDA Received Date: 07/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROTACK
• Outcome Attributed to Adverse Event: Required Intervention