FDA Adverse Event Injury Summary report: N

DRIVE

MDR report key: 10063484 · Received May 15, 2020

Report

Report Number
2438477-2020-00028
Event Type
Injury
Date Received
May 15, 2020
Report Date
May 15, 2020
Manufacturer
HOMECARE ENTERPRISE CO., LTD.
Product Code
IPS
UDI-DI
00822383246451
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A CANE. CANE WAS NOT RETRIEVED FOR EVALUATION. CANE SNAPPED IN HALF WHILE IN USE. END-USER FELL AND BROKE HIS GLASSES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
525403 DRIVE CANE IPS HOMECARE ENTERPRISE CO., LTD. RTL10372BK 00822383246451

Patients

Seq Age Sex Outcome Treatment
1 74 YR