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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 Suction Problem (2170); Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Hematoma (1884); Hemorrhage/Bleeding (1888)
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 a patient experienced two nickel sized purple areas on her labia while using the purewick device. The product was kept in place with mesh under garments. The site is described as a minimal open area with slight bleeding. Gynecologist (gyn) and wound care nurse (woc) were consulted to look at the area. The gyn thought it to be a bruise with maybe a hematoma beneath the surface. The wound care nurse was not sure and will return to have a second look with another set of more experienced eyes. The patient is a slender woman and often holds her legs together. A foley catheter has been placed to monitor output and specific gravity accurately. Per additional information received from the complainant on (b)(6) 2018 via email, barrier cream was applied to the area. The complainant stated that the suction was set at the incorrect suction, although it is unknown what the suction setting was set at. The device had been on the patient for approximately a week.
 
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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 Key7830397
MDR Text Key118719091
Report Number1018233-2018-03869
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
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 Received09/06/2018
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: 08/29/2018 Patient Sequence Number: 1
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