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U.S. Department of Health and Human Services

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

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PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL PUREWICK DRYDOC STATION Back to Search Results
Catalog Number DD15
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)
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 patient developed an unknown injury to their mucosal membrane while using the purewick drydoc station. The patient was prescribed an unknown topical ointment.
 
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Brand NamePUREWICK FEMALE EXTERNAL
Type of DevicePUREWICK DRYDOC 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 Key8775999
MDR Text Key150558746
Report Number1018233-2019-03787
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,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberDD15
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 Received07/24/2019
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: 07/10/2019 Patient Sequence Number: 1
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