FDA Adverse Event Injury Summary report: N

DRIVE MEDICAL

MDR report key: 2255145 · Received August 17, 2011

Report

Report Number
2438477-2011-00012
Event Type
Injury
Date Received
August 17, 2011
Date of Event
June 10, 2011
Report Date
July 18, 2011
Manufacturer
JAN MAO INDUSTRIES, CO., LTD.
Product Code
ITJ
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
CA, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

DRIVE MEDICAL HAS RECEIVED A CUSTOMER COMPLAINT ON A WALKER ORIGINALLY IMPORTED BY DRIVE MEDICAL. IT WAS ALLEGED THAT ONE OF THE LEGS ON THE WALKER BENT CAUSING THE PT TO FALL TO THE GROUND, BREAKING HIS LEFT SHOULDER. THIS MDR REPORT IS BASED ON THE CUSTOMER COMPLAINT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DRIVE MEDICAL WALKER ITJ JAN MAO INDUSTRIES, CO., LTD. 10243 NA

Patients

Seq Age Sex Outcome Treatment
1 NA Required Intervention