MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Catalog Number PCDN1

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product met specifications per the manufacturing record evaluation review for the finished device mmg291 and no nonconformances 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.Additional information was requested, and the following was obtained: please confirm that there was a issue with the secondary shipping material and the primary package of the device (ie open seal) which resulted in the sterility of the device being compromised? only the primary foil package was found damaged.The secondary shipping material and the secondary package remained intact.Will the device and all the material in the photos be returned for evaluation? the device and all the material in the photos will be returned for evaluation.

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 only the primary foil package was found damaged in the newly dispensed product when it was about to open the package to use 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: 01/27/2020.Three pictures were received for analysis.Upon visual inspection of two photos, damage and wrinkles at open foil could be observed; also, a picture of the one open box of product could be observed.However, no conclusion could be reached.Also, one open sample of product was received for analysis.During visual inspection of the sample, the box was received crushed; also, the foil packet was examined and damaged on the top was observed.The damage was examined under magnification and the integrity of the package was not compromised since damage did not cause perforation in the foil.Additionally, wrinkles were noted due to manipulation of the package.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, it could not be determined what may have caused the reported incident.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9542208
• MDR Text Key: 176980853
• Report Number: 2210968-2020-00034
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• 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: 10/31/2020
• Device Catalogue Number: PCDN1
• Device Lot Number: MMG291
• 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