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

Catalog Number UHSL1

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.It was reported that " defects in the mesh connection ", please explain how the product was defective.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and the mesh was implanted.It was reported that there were defects in the mesh connection.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 06/12/2020.Additional information was requested and the following was obtained: please explain how the product was defective.The middle of the product was broken.Is lot number available? no.

• Brand Name: UHS MESH 10CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9981451
• MDR Text Key: 189212972
• Report Number: 2210968-2020-03273
• 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: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UHSL1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2020
• Patient Sequence Number: 1