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

Catalog Number	OPHY2536
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event what was surgical approach (open, laparoscopic or other)? any concurrent surgeries or procedures? were pre-existing adhesions noted during the procedure? location of adhesion? are photos available? how was the mesh secured? if tacks, please indicate how many.Size of mesh? what is the patient's current status?.
Event or Problem Description
It was reported that the patient underwent incisional hernia repair on (b)(6) 2017 and mesh was implanted.The surgery was a success, everything went well.After a few days, the patient went home well, with drain and without major problems.The patient was at home with a drain when a bad smell was coming out of the drain.The doctor asked the patient to return to the hospital, and the doctor saw feces in the drain.The patient underwent another surgical procedure on (b)(6) 2017 and the surgeon found the mesh was stretched out, in perfect condition on the sides, already beginning to form the wall.In the middle of patient¿s belly, the surgeon found an intestinal loop adhered on the mesh, about a coin size.Due to that, the surgeon removed the mesh and left the patient herniated.On (b)(6) 2017, the patient underwent another surgical procedure.The surgeon reported that the patient is in very serious condition, at risk of death, hospitalized and in peritoneotomy.Additional information has been requested.

• Brand Name: ETHICON PHYSIOMESH OPEN
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7213233
• Report Number: 2210968-2018-70408
• Device Sequence Number: 18862557
• Product Code: FTL
• UDI-Device Identifier: 10705031233201
• UDI-Public: 10705031233201
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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 Expiration Date: 09/30/2018
• Device Catalogue Number: OPHY2536
• Device Lot Number: KL8DXCB0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention