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U.S. Department of Health and Human Services

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

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PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL. EXTERNAL FEMALE CATHETER Back to Search Results
Catalog Number PWF030
Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)
Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the patient developed sores and blisters on her backside where the wick is placed in the gluteal cleft. Reportedly, the sores and blisters developed after 3 weeks of use. The patient had been using an over-the-counter salve in conjunction with a medicated salve which was prescribed by her doctor. The patient's daughter advised that the sores were approximately 75% cleared and they planned will wait until she's completely cleared before recatherizing with a catheter from a different lot.
 
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Brand NamePUREWICK FEMALE EXTERNAL.
Type of DeviceEXTERNAL FEMALE 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 Key8091851
MDR Text Key128020326
Report Number1018233-2018-05567
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 consumer,distributor,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPWF030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/20/2018 Patient Sequence Number: 1
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