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U.S. Department of Health and Human Services

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

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PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL Back to Search Results
Catalog Number PWF030
Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
Patient Problems Skin Discoloration (2074); Ulcer (2274); Pressure Sores (2326)
Event Type  Injury  
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 the patient experienced a stage ii pressure ulcer to the perianal skin and labia bilaterally. The skin was assessed and the catheter was changed at least once a shift (q12hr), and more frequently when stooling. Redness was noted the morning of (b)(6) (day#6), subsequently, the catheter was removed. A skin care rn was consulted, who noted the skin injury occurred to the perianal skin and labia bilaterally, which mirrored where the rigid part of the purewick catheter that was in contact with the skin. The use of the purewick catheter was discontinued and the use of incontinence pads resumed. Once removed, the skin was monitored, however no dressing interventions were done. The purewick recommendations were to 'replace every 8-12 hours or if soiled with feces or blood. Assess skin for compromise and perform perinal care prior to placement of a new purewick femal external catheter. 'the purewick recommendations were followed, however further review of purewick materials recommended q2hr removal of the device and skin assessment, which was not done for this patient. It was later reported that the suction was set to 60mmhg while in use. No medical intervention reported.
 
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Brand NamePUREWICK FEMALE EXTERNAL
Type of DevicePUREWICK
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
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7645243
MDR Text Key112577581
Report Number1018233-2018-02458
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 company representative,health
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
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: 06/28/2018 Patient Sequence Number: 1
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