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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE

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C.R. BARD, INC. (COVINGTON) -1018233 URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE Back to Search Results
Catalog Number 485054
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Prolapse (2475); Dyspareunia (4505); Fecal Incontinence (4571)
Event Type  Injury  
Manufacturer Narrative
No sample received.
 
Event Description
The patient's attorney alleged a deficiency against the device. Additional information has been requested, but not yet received. Per additional information received on 19nov2021, the patient has experienced vaginal mesh erosion, dyspareunia, hispareunia, recurrent stage 2 pelvic organ prolapse, defecatory dysfunction and required additional surgical and non-surgical interventions.
 
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Brand NameURETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE
Type of DeviceURETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key12882217
MDR Text Key281321616
Report Number1018233-2021-80100
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2011
Device Catalogue Number485054
Device Lot NumberSGL00473
Was Device Available for Evaluation? No
Event Location Hospital
Date Manufacturer Received11/19/2021
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/29/2021 Patient Sequence Number: 1
Treatment
AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM; AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM; PELVICOL® ACELLULAR COLLAGEN MATRIX
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