• 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 MESHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Not Applicable (3189)
Event Date 01/01/2011
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 a promontofixation coelioscopy in 2011 and the mesh was implanted. It was also reported that during the procedure, association of a 4 x 12 cm plate on which is fixed perpendicularly another plate of 2 x 20 cm. Then the patient was advised to have pregnancy after these operations. New pregnancy was in 2013 with cesarean surgery. Since then the patient experienced urinary and rectal problems, pain with suspicion of appendicitis. Mri, rectal manometry and echographia were performed and there was no cause identified. In 2018, the patient underwent a subtotal hysterectomy and bilateral salpingectomy but the symptoms remain same. Since the procedure, the patient has less vaginal heaviness, and no more menstrual pain but always twinge, tugging and shearing by more or less strong wave. It was also reported that the cervix and ovaries have been preserved and the mesh was attached to the cervix. Currently, the patient is experiencing a lower abdominal, high rectum, lumbar and/or sacrum pain. The patient is also experiencing un-emptied bladder, wants to urinate frequently and must urge to urinate, incompletely empty bladder sensation. 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 Key8445369
MDR Text Key139611440
Report Number2210968-2019-79620
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,foreign,other
Type of Report Initial
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMESHUNK
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2019
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: 03/22/2019 Patient Sequence Number: 1
-
-