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

Catalog Number PCDM1

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. .

Event Description

It was reported that a hole in device packaging was noted and was not sterile.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.During the visual inspection of opened foil, showed excessive manipulation and a hole was noted of right side near of label on the top foil; consistent with excessive manipulation.Also, in the visual inspection of the mesh no defects or damage were observed.Due to that the sample was received open and with excessive manipulation, no conclusion could be reached.

• 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.; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7606163
• MDR Text Key: 111324957
• Report Number: 2210968-2018-73502
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047754
• UDI-Public: 10705031047754
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: PCDM1
• Device Lot Number: LJG352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1