MAUDE Adverse Event Report: ETHICON INC. UHS MESH 10X12 MESH, SURGICAL, POLYMERIC

Catalog Number UHSOV1

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria. Additional summary: a mesh device was returned for analysis. During visual inspection of the open sample, a side of mesh of underlay was partially detached from the flat undyed absorbable film. Per the condition of the sample, the assignable cause of performance loss of integrity - intra op is open welding edge, clearly missing weld defect. A photo was also returned for analysis and during the visual inspection of the picture/photo- a delaminated underlay could be observed. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. How was the procedure completed? any patient consequences? any patient demographics including initials, date of birth, age, wt, gender? provide contact names no one is listed in file?.

Event Description

It was reported that the patient underwent a herniorraphy on (b)(6) 2019 and the mesh was implanted. During the procedure, the mesh detachment found; it was reported that the patch and film was separated partly. Additional information has been requested.

• Brand Name: UHS MESH 10X12
• 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; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8439030
• MDR Text Key: 139432409
• Report Number: 2210968-2019-79589
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2020
• Device Catalogue Number: UHSOV1
• Device Lot Number: ME8DDKB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial