MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH KEYHOLE 4.6X10CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMSK1

Device Problems Delivered as Unsterile Product (1421); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

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.Additional information was requested and the following was obtained: please provide procedure name: no response.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail : no.How was procedure successfully completed? another device was used.The name of the procedure : digestive surgery and cancer / right inguinal hernia to be specified.Attempts are being made to obtain the following information. to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is meant by ¿primary package¿? do you mean the sales carton or the tyvek overwrap (foil/ pouch)? what is meant by ¿secondary package¿? do you mean the tyvek overwrap (foil/ pouch) or the paper folder? can you provide a photo?.

Event Description

It was reported that a patient underwent a digestive surgery on (b)(6) 2021 and the mesh was used.It was reported that upon opening the secondary packaging by the nurse, the primary packaging to contain the protheses was properly closed but when the instrumentalist opened it, he noticed that the prothesis was missing inside.The prothesis was slipped in the secondary packaging, so it was impossible to use as it was not sterile.The device was not used.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint #(b)(4) date sent to the fda: 10/01/2021 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 inc., 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.Attempts have been made to retrieve the device.To date only the package was received however, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: PROLENE MESH KEYHOLE 4.6X10CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12380234
• MDR Text Key: 268676635
• Report Number: 2210968-2021-07773
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMSK1
• Device Lot Number: QHBHPE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• Patient Sequence Number: 1