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 |