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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
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 04/11/2018
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 for evaluation, a follow-up report will then be issued.
 
Event Description
Received letter from attorney alleging that the powerchair armrest collapsed due to a bolt that broke.
 
Manufacturer Narrative
Several on-site inspections of the product were conducted with experts.The product will not be returned to pride for evaluation.
 
Event Description
Received letter from attorney alleging that the power chair armrest collapsed due to a bolt that broke.
 
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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
Manufacturer (Section G)
N/A
n/a
n/a
n/a
Manufacturer Contact
kelly livingston
401 york ave
duryea, PA 18642
5706024056
MDR Report Key7491170
MDR Text Key107494563
Report Number2530130-2018-00051
Device Sequence Number1
Product Code ITI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042612
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/30/2019
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 NumberJ6
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/02/2018
Initial Date FDA Received05/07/2018
Supplement Dates Manufacturer Received05/02/2018
Supplement Dates FDA Received05/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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