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

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN 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
 

ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL Back to Search Results
Device Problem Migration (4003)
Patient Problems Erosion (1750); Fatigue (1849); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Swelling (2091); Burning Sensation (2146); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4). This medwatch report is in response to receipt of maude event report mw5079609. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent a gynecological procedure on (b)(6) 2006 and the mesh was implanted for bladder suspension. The patient hemorrhaged immediately following this surgery and had to be taken back to operating room. The doctor opined that the surgery failed. Later that year the patient had a cadaver iv fascia lata sling put in, but it was too tight and caused urinary retention and was taken down several months later. In 2008, ams devices were implanted such as a mini arc mid ureteral sling and elevate mesh for enterocele and posterior repair. Soon after this surgery, the patient experienced erosion of mesh. The patient also experienced auto immune symptoms, pain in joints, swelling of joints, pain and burning of skin, urge and stress incontinence, hashimotos, severe fatigue, rheumatoid arthritis and lyme disease. It was also reported that eventually this mesh eroded through vaginal wall, causing pain and inability to have intercourse. On (b)(6) 2016, the patient underwent a full removal. The doctor opined that it was one of the most complicated cases, with mesh erosions in multiple locations. It was also reported that it was 4 hours removal, extremely complicated with pain. The patient is still experiencing severe incontinence, and an incisional hernia which allowed bowels to lay on the bladder. In 2017 the patient underwent repairs, which were unsuccessful. It was reported that the patient is still experiencing severe incontinence as well as a myriad of auto immune issue, fatigue and emotional distress. No further information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7945719
MDR Text Key123062756
Report Number2210968-2018-76395
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other,user facility
Type of Report Initial
Report Date 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/08/2018 Patient Sequence Number: 1
-
-