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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; CHAIR, POSITIONING, ELECTRIC
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PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; CHAIR, POSITIONING, ELECTRIC Back to Search Results
Model Number GL358L/LC358L
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bruise/Contusion (1754)
Event Date 07/13/2023
Event Type  malfunction  
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 Description
Consumer alleges he noticed smoke and allegedly saw the hand control was on fire.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Type of Device
CHAIR, POSITIONING, ELECTRIC
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
4001 york avenue
duryea, PA 18642
8008008586
MDR Report Key17446493
MDR Text Key320309474
Report Number2530130-2023-00110
Device Sequence Number1
Product Code INO
UDI-Device Identifier00606509400244
UDI-Public00606509400244
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070950
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 08/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberGL358L/LC358L
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received07/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
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