MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM; MESH, SURGICAL, POLYMERIC

Model Number PVPM

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent an umbilical hernia repair on (b)(6) 2020 and the mesh was used.It was reported that after the placement of the pvpm, the surgeon was pulling out the two blindfolds out of the patient, one of the two has partially detached.It was reported that the device was partially defective and the blindfolds detached with a minimum strain.It was also reported that the device was then removed from the patient.It was reported that the physician put away the product and continued with sutures stitches.The surgery was delayed for 15 minutes due to the reported event.The procedure was successfully completed.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 08/12/2020.H3 evaluation: one open box and one used proceed ventral patch mesh inside a foil of product were received for analysis.During visual inspection of the sample, one strap was partially detached and the other was detached due to the stress applied.In addition, body fluids on the top assembly.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, it could not be determined what may have caused the reported incident.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PVP MEDIUM 6.4CM X 6.4CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10311908
• MDR Text Key: 199986805
• Report Number: 2210968-2020-05489
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132405
• UDI-Public: 10705031132405
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: PVPM
• Device Catalogue Number: PVPM
• Device Lot Number: PDBCLSB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/06/2020
• Patient Sequence Number: 1