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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 LC358M
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Death (1802)
Date of Event 03/18/2018
Type of Reportable Event Death
Additional Manufacturer Narrative
The device has not been available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.
 
Event or Problem Description
It is alleged the lift chair malfunctioned springing upright from a laid back position allegedly causing the consumer to slide onto a tile floor.
 
Event or Problem Description
It is alleged the lift chair malfunctioned springing upright from a laid back position allegedly causing the consumer to slide onto a tile floor.
 
Additional Manufacturer Narrative
The "date of event" was removed.The "date of event" is unknown.The device has not been available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.
 
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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
MDR Report Key10021268
Report Number2530130-2020-00046
Device Sequence Number19612046
Product Code INO
UDI-Device Identifier00606509400251
UDI-Public00606509400251
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K070950
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 04/30/2020
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 NumberLC358M
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/28/2020
Supplement Date Received by Manufacturer04/28/2020
Initial Report FDA Received Date05/04/2020
Supplement Report FDA Received Date05/06/2020
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 Death;
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