FDA Adverse Event Injury Summary report: N

DRIVE MEDICAL

MDR report key: 3049958 · Received April 5, 2013

Report

Report Number
2438477-2013-00009
Event Type
Injury
Date Received
April 5, 2013
Date of Event
September 12, 2012
Report Date
November 20, 2012
Manufacturer
HOMECARE ENTERPRISE CO, LTD
Product Code
KMN
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
FL, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

(B)(4) HAS RECEIVED A LETTER FROM CLAIMANT'S ATTORNEY ABOUT AN INCIDENT INVOLVING A BATH BENCH ALLEGEDLY IMPORTED AND DISTRIBUTED BY (B)(4). CLAIMANT'S ATTORNEY STATED CLAIMANT WAS USING THE BATH BENCH WHEN IT COLLAPSED. CLAIMANT STRUCK HIS HEAD AGAINST THE SHOWER WALL AND CAUSED A BRAIN INJURY. THIS MDR REPORT IS BASED ON A CLAIMANT'S ATTORNEY STATEMENT AND INFORMATION PROVIDED BY (B)(4) ATTORNEY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
139781 DRIVE MEDICAL BATH BENCH KMN HOMECARE ENTERPRISE CO, LTD 12486 NA

Patients

Seq Age Sex Outcome Treatment
1 76 YR Required Intervention