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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 Incontinence (1928); Injury (2348); Prolapse (2475)
Event Type  Injury  
Event Description
The patient¿s attorney alleged a deficiency against the device.Per additional information received, the patient has experienced a large enterocele, rectocele, recurrent stress urinary incontinence with intrinsic sphincter deficiency, posterior vaginal vault prolapse and required one surgical intervention.
 
Event Description
Na.
 
Manufacturer Narrative
Per email received from the fda on 11dec2020, a correction is being submitted for f2 as the initial mdr report inadvertently included the manufacture report no.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE
Type of Device
URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9086347
MDR Text Key159145713
Report Number1018233-2019-05766
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 09/19/2019,01/05/2021
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 Date11/30/2011
Device Catalogue Number485054
Device Lot NumberSGK00788
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2019
Distributor Facility Aware Date12/11/2020
Event Location Hospital
Date Report to Manufacturer09/19/2019
Initial Date Manufacturer Received 08/27/2019
Initial Date FDA Received09/19/2019
Supplement Dates Manufacturer Received12/11/2020
Supplement Dates FDA Received01/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
Patient Weight70
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