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

Catalog Number RML

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Pain (1994); Urinary Frequency (2275); Hematuria (2558); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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 procedure on (b)(6) 2009 and mesh was implanted.It was reported that she experienced vaginal bleeding, hematuria, and urinary frequency.No additional information was provided.

Manufacturer Narrative

(b)(4).It was reported that the patient underwent a gynecological surgical procedure on (b)(6)2009 and mesh was implanted.It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2014 and bs-lynx 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 provide.

• 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: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 5986399
• MDR Text Key: 55885130
• Report Number: 3005075853-2016-05569
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Catalogue Number: RML
• Device Lot Number: ZAB900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYSTEM SLING
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR