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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR W LASR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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ETHICON INC. GYNECARE TVT OBTURATOR W LASR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Model Number 810081L
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2022
Event Type  malfunction  
Event Description
It was reported that a patient underwent a urological procedure on (b)(6) 2022 and mesh was used.The client could not advance with the fixation of the mesh since it was defective.When they placed the mesh by passing the pin, it did not pass, it stopped and that is when it was noted that it had broken at the distal part.There were no adverse patient consequences.Additional information was requested.
 
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.Additional information was requested and the following was obtained: can you identify the product code and lot number of the product that was used? referencia: (b)(4), lot: 3941645.What happened exactly to the product? how exactly is it damaged? at which stage did the issue occur? when they place the mesh by passing the pin, it does not pass, it stops and that is when you see that it has broken at the distal part.Attempts are being made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: (b)(4).
 
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.A manufacturing record evaluation was performed for the finished device batch, and no related non-conformances were identified.
 
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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 Key15729780
MDR Text Key306986963
Report Number2210968-2022-09077
Device Sequence Number1
Product Code OTN
UDI-Device Identifier10705031062306
UDI-Public10705031062306
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K033568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Model Number810081L
Device Catalogue Number810081L
Device Lot Number3941645
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/10/2022
Initial Date FDA Received11/04/2022
Supplement Dates Manufacturer Received12/20/2022
Supplement Dates FDA Received12/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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