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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.
 
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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 Key9086347
MDR Text Key159145713
Report Number1018233-2019-05766
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
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
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2011
Device Catalogue Number485054
Device Lot NumberSGK00788
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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
Date Manufacturer Received12/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/19/2019 Patient Sequence Number: 1
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