FDA Adverse Event Injury Summary report: N

DRIVE MEDICAL

MDR report key: 3030192 · Received March 27, 2013

Report

Report Number
2438477-2013-00008
Event Type
Injury
Date Received
March 27, 2013
Date of Event
October 14, 2012
Report Date
February 28, 2013
Manufacturer
JINHUA TWINSTAR TOOLS CO. LTD.
Product Code
IKX
Adverse Event
Yes
Report Source
Distributor report
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

(B)(4) HAS RECEIVED AN ATTORNEY LETTER FROM (B)(6), ALLEGING AN INCIDENT INVOLVING A SUCTION CUP GRAB BAR ALLEGEDLY IMPORTED AND DISTRIBUTED BY (B)(4). IT IS ALLEGED THAT THE CLAIMANT WAS ATTEMPTING TO BATHE HIMSELF WITH ASSISTANCE OF THE GRAB BAR WHEN THE GRAB BAR FELL CAUSING HIM TO SLIP AND FALL RESULTING IN THREE (3) BROKEN RIBS AND A PUNCTURED LUNG. THIS MDR REPORT IS BASED ON THE INFORMATION PROVIDED BY THE CLAIMANT'S ATTORNEY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
125265 DRIVE MEDICAL SUCTION CUP GRAB BAR IKX JINHUA TWINSTAR TOOLS CO. LTD. 13082 NA

Patients

Seq Age Sex Outcome Treatment
1 63 YR Required Intervention