MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM; MESH, SURGICAL, POLYMERIC

Model Number PVPM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Pain (1994); Obstruction/Occlusion (2422); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4) submitted for the adverse event which occurred on (b)(6) 2011, (b)(4) submitted for the adverse event which occurred on (b)(6) 2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon note a concerning transition point associated with the expected location of the abdominal mesh near the umbilicus.At the umbilicus, she encountered several loops of small intestine which were noted to be densely adherent to one another, and adherent to the abdominal wall.There appeared to be at least one small bowel internal hernia.In total 100 cm of knotted small intestines were resected.The previously placed mesh was noted to be present at the abdominal wall near the umbilical.It was reported that the patient experienced severe pain, dense adhesions, bowel obstructions, constipation, diarrhea, loss of appetite, stress and anxiety.Other procedure is captured under separate file.No additional information was provided.

• Brand Name: PVP MEDIUM 6.4CM X 6.4CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12029144
• MDR Text Key: 262166862
• Report Number: 2210968-2021-05680
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132405
• UDI-Public: 10705031132405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: PVPM
• Device Catalogue Number: PVPM
• Device Lot Number: CM8HKXZ0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2010
• 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