• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL MERSILENE POLYESTER FIBER MESH MESH, SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

JOHNSON & JOHNSON INTERNATIONAL MERSILENE POLYESTER FIBER MESH MESH, SURGICAL Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); 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 surgical procedure on (b)(6) 2002 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

It was reported that the patient underwent a gynecological procedure and mesh was implanted concurrently with sacral colpopexy, burch urethropexy, bilateral salpingo-oophorectomy and cystoscopy. It was reported that pt underwent mesh excision on (b)(6) 2007 by dr. (b)(6) due to vaginal mesh exposure.

 
Manufacturer Narrative

(b)(4). It was reported that following insertion the patient experienced infection, recurrence, bleeding, and vaginal scarring.

 
Manufacturer Narrative

(b)(4). It was reported that following insertion the patient experienced vaginal discharge and prolapse. It was reported that patient underwent multiple removal of mesh on (b)(6) 2007 and (b)(6) 2007 by dr. (b)(6).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMERSILENE POLYESTER FIBER MESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
JOHNSON & JOHNSON INTERNATIONAL
leonardo da vincilaan 15
diegem 1831
BE 1831
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6282442
MDR Text Key65919629
Report Number2210968-2017-60035
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received04/12/2017
Was Device Evaluated By Manufacturer? No
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: 01/27/2017 Patient Sequence Number: 1
-
-