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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT RETROPUBIC DEVICE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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ETHICON INC. GYNECARE TVT RETROPUBIC DEVICE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number 810041BL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 08/06/2021
Event Type  Injury  
Event Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and mesh was implanted.The patient reported experiencing very intense permanent burns from morning to evening, pelvic pain, and pain on the right side of the belly and lower back on the right radiating into the buttock.The patient saw the surgeon again on (b)(6) 2021 who told the patient that the strip was not related to all these pains.The patient was prescribed lyrica 75 mg, drug that shooted the patient.The patient saw the doctor again another time, and asked for a cystoscopy.The doctor told the patient again that the strip was not the cause of the pain and could not do anything.The patient was given a prescription for 50 mg lyrica, and had to restart the pain center to have an appointment.No further information is available as the patient contact details were not disclosed.
 
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.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
 
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Brand Name
GYNECARE TVT RETROPUBIC DEVICE
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 Key18518144
MDR Text Key332928987
Report Number2210968-2024-00421
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K012628
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 Date12/31/2022
Device Catalogue Number810041BL
Device Lot Number3935987
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/04/2024
Initial Date FDA Received01/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2020
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) Required Intervention;
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