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

Model Number PHSL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Failure of Implant (1924)

Event Date 05/29/2019

Event Type  Injury  

Event Description

Ethicon prolene was implanted in my body in (b)(6) 2018, with a seven month's period the mesh ripped into pieces and causes several medical complications and was removed in piece meal.Fda safety report id# (b)(4).

• Brand Name: ETHICON PROLENE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 15806748
• MDR Text Key: 303852758
• Report Number: MW5113305
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PHSL
• Device Catalogue Number: PHSL, PHSL1, PHSL6
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization