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

Catalog Number UHSOV1

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: one opened sample of product code uhsov, lot pabbwcb1 was received for analysis.During visual inspection of the sample, the top foil could be broken; however, this damage was caused when the packet was opened the packet.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to condition of the sample, it is suggested that there was an improper handling of the sample.

Event Description

It was reported that a patient underwent a hernia repair on an unknown date in 2019 and the mesh was implanted.It was reported that during surgery, the package was opened it tore.A like device was used to complete the procedure.There were no adverse patient consequences reported.

• 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
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt 22851 ; GM 22851
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9291616
• MDR Text Key: 168847935
• Report Number: 2210968-2019-89673
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: UHSOV1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1