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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR
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PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR Back to Search Results
Model Number Q6 EDGE 2.0
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hip Fracture (2349)
Event Type  Injury  
Manufacturer Narrative
The device has not been made available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.
 
Event Description
Provider states that the consumer alleges she had just put her son in his chair and turned around to get something and allegedly heard a crash.She alleges the armrest broke and dropped down allegedly causing her son to fall out of the chair.
 
Event Description
Provider states that the consumer alleges she had just put her son in his chair and turned around to get something and allegedly heard a crash.She alleges the armrest broke and dropped down allegedly causing her son to fall out of the chair.
 
Manufacturer Narrative
Only the armrests were returned for evaluation.Failure to heed product warnings.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Type of Device
POWERED WHEELCHAIR
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea PA 18642
MDR Report Key10611988
MDR Text Key209339418
Report Number2530130-2020-00089
Device Sequence Number1
Product Code ITI
UDI-Device Identifier00606509200042
UDI-Public00606509200042
Combination Product (y/n)N
PMA/PMN Number
K042612
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberQ6 EDGE 2.0
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2020
Date Manufacturer Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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