MAUDE Adverse Event Report: ETHICON INC. PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number PHSMUNK

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

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.The following information was requested, but unavailable: was there any adverse consequence associated with the patient? please provide procedure name and date.Please provide event date.Please provide lot numb.Please provide product code.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and the mesh was used.It was reported that a surgeon experienced the prolene soft mesh, mid-weight, unraveling after being cut to desired size.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 07/27/2020.

• Brand Name: PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10330169
• MDR Text Key: 200653033
• Report Number: 2210968-2020-05604
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K984220
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PHSMUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Patient Sequence Number: 1