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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 Problem Patient-Device Incompatibility (2682)
Patient Problems Abrasion (1689); Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Irritation (2076); Reaction (2414)
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.
 
Event Description
It was reported that the patient experienced a latex allergic reaction with the use of the purewick device. The patient reported that she was not advised at the hospital that the wick contained latex and as a result, she developed sores "all over her body. " it was also noted that the patient had a sore between her leg that "opened up and bled. " the allergic reaction was treated with prescribed silver sulfadiazine (silvadene) cream.
 
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Brand NamePUREWICK FEMALE EXTERNAL.
Type of DevicePUREWICK FEMALE EXTERNAL
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 Key7671563
MDR Text Key113501793
Report Number1018233-2018-02677
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,distributor,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPWF030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2018
Was Device Evaluated by Manufacturer? Yes
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: 07/09/2018 Patient Sequence Number: 1
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