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

Catalog Number GYNUNK

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a hysteropexy procedure, anterior repair and posterior repair on (b)(6) 2008 and mesh was implanted.The patient experienced mesh erosion.No additional information was provided at this time.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6941618
• MDR Text Key: 89234356
• Report Number: 2210968-2017-70475
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2009
• Device Catalogue Number: GYNUNK
• Device Lot Number: TMP223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2017
• Date Device Manufactured: 11/29/2004
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1