• 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 TVT OBTURATOR W LASR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

  • 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 TVT OBTURATOR W LASR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Model Number 810081L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Date 11/01/2021
Event Type  Injury  
Event Description
It was reported that a patient underwent a sling procedure on 11/17/2021 and mesh was implanted.The patient reported experiencing intense pain in adductors, buttocks, hips, thighs, tingling legs and feet along with significant pelvic pain.The patient has also experienced loss of physical abilities and inability to move for periods.The patient reported that the urologist did not explain the course of the intervention nor the risks of complications.No further information is available.
 
Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GYNECARE TVT OBTURATOR W LASR
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits godet 20
neuchatel 2000
SZ   2000
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
9083863534
MDR Report Key16055079
MDR Text Key306241039
Report Number2210968-2022-10670
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K033568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model Number810081L
Device Catalogue Number810081L
Device Lot Number3938440
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/07/2022
Initial Date FDA Received12/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-