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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 HD
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes Abrasion (1689); Bruise/Contusion (1754)
Date of Event 05/24/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Alleged incident was not identified as product related.User error.
 
Event or Problem Description
Alleges fell in bathroom, hit head on the grab bar, and ended up underneath the chair for about 9 hours until someone found her.Customer feels it was not due to anything about chair but just getting used to using chair.
 
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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 Key11946007
Report Number2530130-2021-00058
Device Sequence Number4015491
Product Code ITI
UDI-Device Identifier00606509200059
UDI-Public00606509200059
Combination Product (Y/N)N
Initial Reporter StateNY
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) 06/03/2021
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 HD
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 06/02/2021
Initial Report FDA Received Date06/07/2021
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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