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

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.

• Brand Name: BARD PUREWICK
• Type of Device: EXTERNAL FEMALE CATHETER / COLLECTOR URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 7789014
• MDR Text Key: 117567821
• Report Number: MW5079177
• Device Sequence Number: 1
• Product Code: NZU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: PUREWICK
• Device Catalogue Number: PWF030
• Device Lot Number: MYCRWF31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 60