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U.S. Department of Health and Human Services

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

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ETHICON INC. GYNECARE TVT OBTURATOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Model Number 810081
Device Problem Migration (4003)
Patient Problems Abdominal Pain (1685); Erosion (1750); Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Discomfort (2330); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2020 and mesh was implanted due to stress incontinence.It was reported that the patient underwent removal surgery on (b)(6) 2021.It was reported that the patient experienced vaginal pain, pain with coitus, muscular groin pain, leg pain, abdominal pain, walking difficulty, foreign material in vagina, urethral scarring, bleeding, discomfort and mesh exposure following surgery.No additional information was provided.
 
Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
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Brand Name
GYNECARE TVT OBTURATOR
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
SZ  
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13598903
MDR Text Key287134527
Report Number2210968-2022-01315
Device Sequence Number1
Product Code OTN
UDI-Device Identifier10705031000346
UDI-Public10705031000346
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K033568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2022
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 Date12/31/2020
Device Model Number810081
Device Catalogue Number810081
Device Lot Number3936026
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/01/2022
Initial Date FDA Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
Patient SexFemale
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