• 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
Catalog Number UNK_GYNECARE MESH UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146); Ambulation Difficulties (2544)
Event Date 07/18/2007
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 an anterior and posterior vaginal compartment repair by vaginal approach, sacrospinous colpopexy, cystoscopy with urethroscopy and rectocele and cystocele repair procedure on (b)(6) 2007 and the mesh was implanted. Since implantation, the patient experienced burning sensation and pain in vagina and back. As per patient, the doctor opined that for the patient¿s age the arthritis in spine is more than what it should appear for the age - auto immune response to the implant. As per patient, they could not sit properly for over one year and even now after about 1 hr the vagina and pubic area become inflamed and extremely sore. The patient is taking norspan patch, panadol osteo, nexium to counteract the celebrex for inflammation. The patient experienced ongoing uti¿s and dyspareunia and in the vagina, there is a ridge or hard area. The patient is experiencing fatigue, pain from the base of skull down the length of their spine and pain in fingers, which has large lumps on the knuckles. The patient is experiencing bowel problems: diarrhea and next day constipation and has constant visits to doctors for pain management and physical therapy. The patient cannot stand for long periods of time. 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 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7028845
MDR Text Key91936778
Report Number2210968-2017-71235
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_GYNECARE MESH UNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/14/2017 Patient Sequence Number: 1
-
-