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

Catalog Number RML

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Hematuria (2558); Not Applicable (3189)

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.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.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2001 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

Patient codes: (b)(4) - urinary problems, recurrent granulation tissue, vaginal lesion, (b)(4)- surgical intervention.It was reported that following insertion the patient experienced infection, urinary problems, bleeding, dyspareunia, vaginal scarring, urinary retention, urinary frequency, urgency, dysuria, urinary tract infection, hematuria, and vaginal discharge.It was reported that patient underwent mesh revision, vaginal revision, release of adhesion, and cystourethroscopy on (b)(6)2006 by dr.(b)(6) due to vaginal bleeding and vaginal adhesion at st.(b)(6).It was reported that patient underwent excision of vaginal lesion on (b)(6)2004 by dr.(b)(6) due to recurrent granulation tissue, vaginal lesion and persistent vaginal bleeding at (b)(6).It was reported that patient underwent sling revision on (b)(6)2010 by dr.(b)(6) due to retropubic abscess at (b)(6).It was reported that the patient underwent a gynecological procedure and mesh was implanted concurrently with transvaginal hysterectomy, anterior and posterior colporrhaphy, sling urethropexy, and colpoperineorrhaphy.

Manufacturer Narrative

It was reported that the patient underwent mesh removal on (b)(4) 2010. .

• Brand Name: MERS MESH
• 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: 7247899
• MDR Text Key: 99222492
• Report Number: 2210968-2018-70496
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2005
• Device Catalogue Number: RML
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2018
• Date Device Manufactured: 04/10/2000
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR