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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 J6
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Fracture, Arm (2351)
Date of Event 01/26/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This was not a product problem.This was user error.Filing due to injuries sustained from alleged incident.
 
Event or Problem Description
Alleges user was on a hill and got stuck in mud.Tires started spinning, so he put chair in freewheel and it rolled down the hill and chair flipped over.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Common Device Name
POWERED WHEELCHAIR
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
182 susquehanna ave
n/a
exeter PA 18643
MDR Report Key7251997
Report Number2530130-2018-00022
Device Sequence Number1342850
Product Code ITI
UDI-Device Identifier00606509100014
UDI-Public00606509100014
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K042612
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/06/2018
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 NumberJ6
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/01/2018
Initial Report FDA Received Date02/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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