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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 LC220
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Burn(s) (1757)
Event Type  Injury  
Manufacturer Narrative
The device has not yet been made available for evaluation.Should the device become available or further information be received, a follow-up report will then be issued.
 
Event Description
Alleges the hand control was sitting in the consumer's lap not in use when the hand control burned his hand.Alleges hand control caught on fire.Allegedly electricity went through consumers hand and out.
 
Manufacturer Narrative
Only the hand control was returned for evaluation.A damaged strain relief was found with an unknown cause.
 
Event Description
Alleges the hand control was sitting in the consumer's lap not in use when the hand control burned his hand.Alleges hand control caught on fire.Allegedly electricity went through consumers hand and out.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Type of Device
ELECTRIC POSITIONING CHAIR
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea PA 18642
MDR Report Key11279041
MDR Text Key230259462
Report Number2530130-2021-00012
Device Sequence Number1
Product Code INO
Combination Product (y/n)N
PMA/PMN Number
K070950
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 04/26/2021
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
Device Operator Lay User/Patient
Device Model NumberLC220
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Initial Date Manufacturer Received 02/01/2021
Initial Date FDA Received02/04/2021
Supplement Dates Manufacturer Received02/01/2021
Supplement Dates FDA Received04/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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