Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR Back to Search Results
Model Number JAZZY PASSPORT
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Bruise/Contusion (1754)
Date of Event 09/16/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation as of yet.Should the device or further information become available, a follow-up report will then be issued.
 
Event or Problem Description
Provider alleges the consumer's wife alleges the chair allegedly folded while the consumer was driving and allegedly threw the consumer out.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRIDE MOBILITY PRODUCTS
Common Device Name
POWERED WHEELCHAIR
MDR Report Key12512655
Report Number2530130-2021-00101
Device Sequence Number3321874
Product Code ITI
UDI-Device Identifier00606509100212
UDI-Public00606509100212
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K011993
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/21/2021
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
Operator of Device Lay User/Patient
Device Model NumberJAZZY PASSPORT
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/20/2021
Initial Report FDA Received Date09/22/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured04/28/2020
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
-
-