FDA Adverse Event Other Summary report: N

GUARDIAN

MDR report key: 320691 · Received March 16, 2001

Report

Report Number
2020334-2001-00007
Event Type
Other
Date Received
March 16, 2001
Report Date
March 16, 2001
Manufacturer
SUNRISE MEDICAL/PCP DIVISION
Product Code
ITJ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CO, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT THE USER LOST BALANCE WHILE USING THE WALKER. THE USER FELL ONTO THE WALKER BREAKING WRIST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
11812 GUARDIAN WALKER ITJ SUNRISE MEDICAL/PCP DIVISION 7990 NA

Patients

Seq Age Sex Outcome Treatment
1 58 YR Other