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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETEX SUP URETHRAL SUPPORT SYSTEM

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C.R. BARD, INC. (COVINGTON) -1018233 URETEX SUP URETHRAL SUPPORT SYSTEM Back to Search Results
Catalog Number 485013
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Injury (2348)
Event Type  Injury  
Event Description
The patient's attorney alleged a deficiency against the device. Per additional information received, the patient has experienced recurrent urinary stress incontinence. She has required one surgical intervention.
 
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Brand NameURETEX SUP URETHRAL SUPPORT SYSTEM
Type of DeviceURETEX SUP URETHRAL SUPPORT SYSTEM
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8996576
MDR Text Key158630519
Report Number1018233-2019-05575
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/11/2019,01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number485013
Device Lot NumberSGJ00236
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/11/2019
Distributor Facility Aware Date12/11/2020
Event Location Hospital
Date Report to Manufacturer09/11/2019
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 Initial

Patient Treatment Data
Date Received: 09/11/2019 Patient Sequence Number: 1
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