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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
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Muscle/Tendon Damage (4532)
Date of Event 03/18/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should the device or further information become available, a follow-up report will then be issued.
 
Event or Problem Description
Consumer alleges while getting out his chair, the armrest allegedly broke allegedly causing him to fall forward.To prevent from falling forward, consumer tried to grab the other armrest allegedly causing his right arm to twist.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Common Device Name
POWERED WHEELCHAIR
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea PA 18642
MDR Report Key12189557
Report Number2530130-2021-00077
Device Sequence Number19163318
Product Code ITI
UDI-Device Identifier00606509200028
UDI-Public00606509200028
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K042612
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/15/2021
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
Operator of Device Lay User/Patient
Device Model NumberQ6 EDGE
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/07/2021
Initial Report FDA Received Date07/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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