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U.S. Department of Health and Human Services

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

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PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL; DRYDOC STATION Back to Search Results
Catalog Number DD15
Device Problem Increase in Suction (1604)
Patient Problems No Consequences Or Impact To Patient (2199); 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.
 
Event Description
It was reported that the drydoc suction was too strong.No medical intervention was reported.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿check patient tubing for blockage or flow restriction such as pinched or kinked tubing¿.Correction: d10.H11:section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported that the drydoc suction was too strong.No medical intervention was reported.
 
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Brand Name
PUREWICK FEMALE EXTERNAL
Type of Device
DRYDOC STATION
Manufacturer (Section D)
PUREWICK CORPORATION ¿ 3012224959
203 gillespie way
el cajon CA 92020
MDR Report Key8654849
MDR Text Key146799442
Report Number1018233-2019-02828
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741151781
UDI-Public(01)00801741151781
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberDD15
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/10/2019
Initial Date FDA Received05/30/2019
Supplement Dates Manufacturer Received07/08/2019
Supplement Dates FDA Received07/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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