MAUDE Adverse Event Report: ETHICON INC. MERSILENE POLYESTER FIBER MESH MESH, SURGICAL, POLYMERIC

Catalog Number RMS

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent to the fda: 12/20/2016. (b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh was implanted. It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. It was reported that the patient has undergone multiple surgeries and revisionary procedures. No additional information was provided.

Manufacturer Narrative

(b)(4). It was reported that patient underwent mesh removal on (b)(6) 2011 by dr. (b)(6) at (b)(6) hospital. It was reported that following insertion the patient experienced urinary problems, recurrence and infection.

Manufacturer Narrative

(b)(4). It was reported that following insertion the patient experienced cystocele. In addition, a device history review has been inserted into the file.  this review indicates that there was no quality concerns associated with the manufacturing process.

• Brand Name: MERSILENE POLYESTER FIBER MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6188888
• MDR Text Key: 62839167
• Report Number: 2210968-2016-60109
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2012
• Device Catalogue Number: RMS
• Device Lot Number: ZKE853
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/20/2016 Patient Sequence Number: 1