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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; WHEELCHAIR, POWERED

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PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; WHEELCHAIR, POWERED Back to Search Results
Model Number Q6 EDGE HD (ILEVEL)
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/18/2023
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.
 
Event or Problem Description
Tech alleges consumer was using magnetic charger port on js and flames allegedly "shot out of the port"- provider alleges when visually inspecting, there were allegedly burnt connections and discoloration throughout.
 
Event or Problem Description
Tech alleges consumer was using magnetic charger port on js and flames allegedly "shot out of the port"- provider alleges when visually inspecting, there were allegeldy burnt connections and discoloration throughout.
 
Additional Manufacturer Narrative
Customer abuse.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Common Device Name
WHEELCHAIR, POWERED
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea 18642
Manufacturer (Section G)
N/A
n/a
n/a
n/a
Manufacturer Contact
kelly livingston
401 york avenue
duryea 18642
8008008586
MDR Report Key16983021
Report Number2530130-2023-00052
Device Sequence Number20546282
Product Code ITI
UDI-Device Identifier00606509200059
UDI-Public00606509200059
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K143383
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 05/02/2024
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
Operator of Device Lay User/Patient
Device Model NumberQ6 EDGE HD (ILEVEL)
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/18/2023
Supplement Date Received by Manufacturer05/18/2023
Initial Report FDA Received Date05/23/2023
Supplement Report FDA Received Date05/02/2024
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured03/27/2023
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Reuse
Patient Sequence Number1
Patient SexMale
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