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 |