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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL. FEMALE EXTERNAL CATHETER

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PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL. FEMALE EXTERNAL CATHETER Back to Search Results
Catalog Number PWF030
Device Problems Fluid Leak (1250); Increase in Suction (1604)
Patient Problems Edema (1820); Patient Problem/Medical Problem (2688)
Event Date 08/11/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
 
Event Description
It was reported that while doing perineal care on a patient, the patient had an impression of the catheter in her perineal area, and the area did not blanch for in less than 3 seconds. No skin breakdowns were noted. The external catheter was discontinued and replaced with an indwelling foley catheter. The patient was post stemi and cardiogenic shock requiring levophed, bumex, iabp, and stents. The patient had generalized edema in the lower extremities including the perineum, which was "severely edematous". An indwelling foley catheter was discontinued and replaced with an external female catheter to catch incontinent urine. The external catheter caught approximately 50% of the patient's urine. Due to incontinence and leaking around the external catheter, frequent peri-care was being performed. Per additional information received from the complainant via email on (b)(6) 2018: the setting of the suction is unknown. The area was not treated with anything. The patient had pre-existing edema including in the area of her perineum.
 
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Brand NamePUREWICK FEMALE EXTERNAL.
Type of DeviceFEMALE EXTERNAL CATHETER
Manufacturer (Section D)
PUREWICK CORPORATION ¿ 3012224959
203 gillespie way
el cajon CA 92020
Manufacturer (Section G)
PUREWICK CORPORATION ¿ 3012224959
203 gillespie way
el cajon CA 92020
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7888996
MDR Text Key121462912
Report Number1018233-2018-04243
Device Sequence Number1
Product Code NZU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2020
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
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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