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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); Insufficient Information (3190)
Patient Problem 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 developed a "pressure ulcer along the line of the purewick. ".
 
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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 Key7376816
MDR Text Key103661085
Report Number1018233-2018-00976
Device Sequence Number1
Product Code NNW
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 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
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: 03/28/2018 Patient Sequence Number: 1
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