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

Catalog Number PVPS

Device Problems Peeled/Delaminated (1454); Tear, Rip or Hole in Device Packaging (2385); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device has been received; evaluation in progress. A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Event Description

It was reported that the patient underwent an open hernia repair on (b)(6) 2019 and mesh was used. During setup for the procedure, the device was opened and the device was found to be defective. A second like device was used to complete the procedure with no adverse patient consequences reported.

• 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
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409 d22841; norderstedt
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8345416
• MDR Text Key: 136509812
• Report Number: 2210968-2019-78923
• Device Sequence Number: 1
• Product Code: FTL
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2020
• Device Catalogue Number: PVPS
• Device Lot Number: MK8CQXB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial