MAUDE Adverse Event Report: ETHICON INC. PVP SMALL 4.3CM X 4.3CM; MESH, SURGICAL, POLYMERIC

Catalog Number PVPS

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

Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Obstruction/Occlusion (2422); Not Applicable (3189)

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.

Event Description

It was reported by an attorney that the patient underwent umbilical hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent incarcerated umbilical hernia repair surgery on (b)(6) 2018 during which the surgeon noted that ¿it was found to contain a loop of small bowel densely adherent to the undersurface of the previously placed mesh, which measured approximately 2 x 2 cm.The bowel loop was carefully dissected off the underlying mesh and the mesh sac was sent as a separate specimen.¿ no additional information is provided.

Manufacturer Narrative

Date sent to fda: 1/21/2019.

Manufacturer Narrative

Date sent to fda: 12/20/2019.Additional narrative: it was reported that the patient underwent removal surgery on (b)(6) 2018.It was reported that the patient experienced severe pain, bowel obstruction, nausea and inflammation.(b)(4).

• Brand Name: PVP SMALL 4.3CM X 4.3CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8205549
• MDR Text Key: 131701446
• Report Number: 2210968-2018-77823
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132412
• UDI-Public: 10705031132412
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: PVPS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/30/2018
• Supplement Dates Manufacturer Received: 01/16/2019; 12/13/2019
• Supplement Dates FDA Received: 01/21/2019; 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR