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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. BARD PUREWICK EXTERNAL FEMALE CATHETER / COLLECTOR URINE, POWERED, NON INDWELLING CATHETER

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C. R. BARD, INC. BARD PUREWICK EXTERNAL FEMALE CATHETER / COLLECTOR URINE, POWERED, NON INDWELLING CATHETER Back to Search Results
Model Number PUREWICK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Incontinence (1928)
Event Date 08/11/2018
Event Type  No Answer Provided  
Event Description
Pt admitted on (b)(6) 2018 post stemi and cardiogenic shock requiring levophed, bumex, iabp and stents. Pt had generalized edema in lower extremities including perineum which was "severely edematous. " foley was discontinued and removed on (b)(6) 2018 and replaced with an external female catheter to "catch incontinent urine. " the external catheter was catching approx 50% of pt's urine. Due to incontinence and leaking around external catheter, frequent peri-care was being performed. During re-assessment of the labia area it was noted that external catheter had left "catheter impression" and "did not blanch in <3secs" (there was no skin breakdown in labia area that was noted). The external catheter was discontinued (on (b)(6) 2018) and replaced with an indwelling foley catheter.
 
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Brand NameBARD PUREWICK
Type of DeviceEXTERNAL FEMALE CATHETER / COLLECTOR URINE, POWERED, NON INDWELLING CATHETER
Manufacturer (Section D)
C. R. BARD, INC.
covington GA 30014
MDR Report Key7789014
MDR Text Key117567821
Report NumberMW5079177
Device Sequence Number1
Product Code NZU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2020
Device Model NumberPUREWICK
Device Catalogue NumberPWF030
Device Lot NumberMYCRWF31
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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