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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 Q6 EDGE 2.0
Device Problem Unintended Movement (3026)
Patient Problem Hip Fracture (2349)
Event Date 03/30/2020
Event Type  Injury  
Manufacturer Narrative
Provider replaced motors after doing an evaluation of the unit.The unit was working properly and any alleged issues the consumer is having is consumer error.
 
Event Description
Consumer alleges unit took off on its own and he was allegedly thrown form the chair and pinned down.
 
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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
Manufacturer (Section G)
N/A
n/a
n/a
n/a,
Manufacturer Contact
kelly livingston
401 york ave
duryea, pa 
6024056
MDR Report Key10178866
MDR Text Key195923461
Report Number2530130-2020-00058
Device Sequence Number1
Product Code ITI
UDI-Device Identifier00606509200042
UDI-Public00606509200042
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042612
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberQ6 EDGE 2.0
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/17/2020
Initial Date FDA Received06/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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