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U.S. Department of Health and Human Services

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

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PUREWICK CORPORATION ¿ 3012224959 PUREWICK DRYDOC STATION Back to Search Results
Catalog Number DD15
Device Problems Increase in Suction (1604); Suction Problem (2170)
Patient Problems Skin Discoloration (2074); No Known Impact Or Consequence To Patient (2692)
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 suction on the drydoc machine is too high. Per additional information received via phone by complainant on (b)(6) 2018, she noted that upon receipt of the drydoc machine, she did not attempt to adjust the settings because she assumed the suction had been preset. She was unsure of the exact setting the device, however, she noted that the suction was too high for the patient and resulted in redness of the entire area.
 
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Brand NamePUREWICK DRYDOC STATION
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 Key7731852
MDR Text Key115525786
Report Number1018233-2018-03096
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberDD15
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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