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

Catalog Number PCDL1

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Attempts are being made to retrieve the device.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.

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 the aluminum packaging was punctured, compromising the sterility of the mesh.It was also reported that surgery was delayed five minutes.A new mesh was used to successfully complete the procedure.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 01/27/2020.H6 method codes: 3331.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 03/03/2020.Corrected b5 narrative: it was reported that a patient underwent a ventral hernia repair procedure on (b)(6) 2020 and the mesh was implanted.It was reported that the aluminum packaging was punctured, compromising the sterility of the mesh.It was also reported that surgery was delayed five minutes.A new mesh was used to successfully complete the procedure.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 03/03/2020.H3 evaluation: during the visual inspection of the pictures, a sample with two holes at the foil could be observed.However, no conclusion could be reached on how this happened as the sample was not returned for analysis.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9631379
• MDR Text Key: 195224927
• Report Number: 2210968-2020-00711
• 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,Followup,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: PCDL1
• Device Lot Number: MJG210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 01/09/2020; 03/03/2020; 03/03/2020
• Supplement Dates FDA Received: 01/27/2020; 03/03/2020; 03/03/2020
• Patient Sequence Number: 1