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U.S. Department of Health and Human Services

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

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C. R. BARD, INC. PUREWICK FEMALE EXTERNAL CATHETER COLLECTOR, URINE, POWERED NON-INDWELLING CATHETER Back to Search Results
Catalog Number PWF030
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem Injury (2348)
Event Date 05/05/2019
Event Type  Injury  
Event Description
Purewick female external catheter applied to female pt to manage incontinence. Packaging indicates attach to suction at > or
=
40 mmhg, with no upper limit indicated. Suction applied at 100 mmgh or more. Pt developed pressure injury.
 
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Brand NamePUREWICK FEMALE EXTERNAL CATHETER
Type of DeviceCOLLECTOR, URINE, POWERED NON-INDWELLING CATHETER
Manufacturer (Section D)
C. R. BARD, INC.
MDR Report Key8624867
MDR Text Key145785814
Report NumberMW5086777
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
Type of Report Initial
Report Date 05/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2020
Device Catalogue NumberPWF030
Device Lot NumberMYC20997
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 05/17/2019 Patient Sequence Number: 1
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