MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMM3

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch mpj356, and no non-conformance's were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and the mesh was implanted.It was reported that the inner package was found damaged in the newly dispensed product when the outer box was opened to get prepared for surgery.Another like device was used to complete the procedure.There were no patient consequences reported.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 01/22/2020.Additional information: d10.H3 evaluation: upon visual inspection of video, an open overwrap of product could be observed.One partially open sample of product was returned for analysis.During visual inspection of the sample, the overwrap was partially open of the peel-able area.The seal mark was present at the copolymer and tyvek which indicate that the package was sealed.Also the seal margin met the requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.No conclusion could be reached as to what may have caused the reported incident.

• Brand Name: PROLENE MESH 15X15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9542249
• MDR Text Key: 193603583
• Report Number: 2210968-2020-00036
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: PMM3
• Device Lot Number: MPJ356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Date Manufacturer Received: 01/09/2020
• Patient Sequence Number: 1