FDA Adverse Event Injury Summary report: N

PRIDE MOBILITY PRODUCTS

MDR report key: 2938163 · Received January 31, 2013

Report

Report Number
2530130-2013-00008
Event Type
Injury
Date Received
January 31, 2013
Date of Event
January 3, 2013
Report Date
January 31, 2013
Manufacturer
PRIDE MOBILITY PRODUCTS
Product Code
ITI
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
SERVICE PERSONNEL

Narratives

Additional Manufacturer Narrative · 1

CONSUMER STATED THAT THE SEAT WAS ADJUSTED IMPROPERLY DURING HER LAST REPAIR FROM (B)(4) (A DIVIISON OF INVACARE CORPORATION). THE SEAT WAS ADJUSTED TOO HIGH AND THEREFORE THE CONSUMER WAS NOT ABLE TO TRANSFER PROPERLY WHICH CAUSED THE FALL. A PRIDE REPRESENTATIVE VISITED CONSUMER, REPLACED BATTERIES, AND DID AN OVERALL CHECK OF THE DEVICE. THE DEVICE IS WORKING PROPERLY.

Description of Event or Problem · 1

CUSTOMER ALLEGES THAT SHE WENT TO SIT IN THE CHAIR AND FELL AND BROKE HER LEG FROM THE FALL. CONSUMER WENT TO THE HOSPITAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
42675 PRIDE MOBILITY PRODUCTS POWERED WHEELCHAIR ITI PRIDE MOBILITY PRODUCTS JAZZY 600XL

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization