MAUDE Adverse Event Report: ETHICON INC. UHS MESH 7.5CM MESH, SURGICAL, POLYMERIC

Catalog Number UHSM1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4). Date sent to the fda: 10/18/2018. 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 during use, the onlay patch was slightly broken at the underlay patch. Please indicate if the device was torn, frayed, separating and falling apart? it was reported that the patient's outcome was not good after device use, please elaborate and describe what the patient's experience was, that was not good, what was the negative consequence the patient experienced? please provide the following: name of procedure?; did event occur intra-op?; how was the procedure completed? provide lot number, only the actual lot number of the device used for this procedure? patient demographics if available: pt's initials, date of birth, age, wt at time of surgery.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and mesh was used. During use, it was found that the onlay patch was slightly broken at the underlay patch, and the patient's outcome was not good after use, so it was discarded and could no longer be used. There were no adverse patient¿s consequences reported. Additional information has been requested.

• Brand Name: UHS MESH 7.5CM
• 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: 7979406
• MDR Text Key: 124374590
• Report Number: 2210968-2018-76620
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UHSM1
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial