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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL PUREWICK DRY DOC STATION

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PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL PUREWICK DRY DOC STATION Back to Search Results
Catalog Number DD15
Device Problem Increase in Suction (1604)
Patient Problems Laceration(s) (1946); Pain (1994); Skin Tears (2516)
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 the catheter suctioned to the patient becoming stuck to the skin. Allegedly, the patient's skin on her labia tore, and the patient experienced pain. No medical intervention reported. It was later reported by the patient via phone on (b)(6) 2018, the area was treated otc with (b)(6).
 
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Brand NamePUREWICK FEMALE EXTERNAL
Type of DevicePUREWICK DRY DOC STATION
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 Key7752625
MDR Text Key116463500
Report Number1018233-2018-03370
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 distributor,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDD15
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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