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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK PATIENT TUBING

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PUREWICK CORPORATION ¿ 3012224959 PUREWICK PATIENT TUBING Back to Search Results
Catalog Number 70PH
Device Problems Disconnection (1171); Suction Problem (2170)
Patient Problems Skin Irritation (2076); 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 purewick patient tubing disconnected from the purewick device; therefore, the purewick patient tubing allegedly suctioned to the patient's skin for an entire night. The patient allegedly experienced a blister and the home nurse was called to shave and clean the patient 's blister.
 
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Brand NamePUREWICK PATIENT TUBING
Type of DevicePUREWICK PATIENT TUBING
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 Key7639628
MDR Text Key112557791
Report Number1018233-2018-02429
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 Other Caregivers
Type of Report Initial,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number70PH
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 Received07/05/2018
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

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