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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR
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PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR Back to Search Results
Model Number QUANTUM 4FRONT
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bruise/Contusion (1754); Headache (1880)
Event Date 02/03/2020
Event Type  Injury  
Manufacturer Narrative
The device has not been made available for evaluation as of yet.Should further information or the device become available, a follow-up report will then be completed.
 
Event Description
Alleges that while consumer was reclining in her chair to reposition the rear casters gave way, throwing her out of the chair.
 
Manufacturer Narrative
The device was returned and evaluated.The evaluation concluded likely abuse.
 
Event Description
Alleges that while consumer was reclining in her chair to reposition the rear casters gave way, throwing her out of the chair.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Type of Device
POWERED WHEELCHAIR
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea, pa
MDR Report Key9720125
MDR Text Key190605858
Report Number2530130-2020-00024
Device Sequence Number1
Product Code ITI
UDI-Device Identifier00606509200035
UDI-Public00606509200035
Combination Product (y/n)N
PMA/PMN Number
K143383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberQUANTUM 4FRONT
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2020
Date Manufacturer Received02/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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