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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR

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PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR Back to Search Results
Model Number PLR975L
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been made available for evaluation.Should further information of the device become available, a follow-up report will be issued.
 
Event or Problem Description
Consumer alleges there was a small fire with the usb iphone charger cord plugged into the remote.
 
Event or Problem Description
Consumer alleges there was a small fire with the usb iphone charger cord plugged into the remote.
 
Additional Manufacturer Narrative
There was no evidence of fire on the lift chair or the hand control.The usb charging feature in the hand control performed as designed when tested.(both hand controls).
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Common Device Name
ELECTRIC POSITIONING CHAIR
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea PA 18642
Manufacturer (Section G)
N/A
n/a
n/a
n/a
Manufacturer Contact
kelly livingston
401 york ave
duryea, PA 18642
8008008586
MDR Report Key15123930
Report Number2530130-2022-00066
Device Sequence Number20665213
Product Code INO
UDI-Device Identifier00606509401050
UDI-Public00606509401050
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K091578
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) 09/27/2022
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 NumberPLR975L
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 07/26/2022
Supplement Date Received by Manufacturer07/26/2022
Initial Report FDA Received Date07/28/2022
Supplement Report FDA Received Date09/28/2022
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured10/31/2018
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 Unknown
Patient Sequence Number1
Patient SexMale
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