FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 1616462
·
Received February 23, 2010
Report
- Report Number
- 2438477-2010-00007
- Event Type
- Injury
- Date Received
- February 23, 2010
- Date of Event
- June 23, 2009
- Report Date
- February 24, 2010
- Manufacturer
- GENTRY HARDWARE PRODUCTS CO, LTD.
- Product Code
- ILS
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ONE OF DRIVE'S CUSTOMER HAS RECEIVED A NOTICE OF CLAIM FROM AN ATTORNEY'S OFFICE REGARDING A BATH STOOL ORIGINALLY IMPORTED BY DRIVE. IT WAS ALLEGED THAT THE (B)(6) CLAIMANT FELL FROM THE STOOL AND RECEIVED MULTIPLE FRACTURES ON RIBS, KNEE AND LEG. IMMEDIATELY AFTER BEING NOTIFIED WITH THIS ADVERSE EVENT, DRIVE HAD CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFO ABOUT THE EVENT. DRIVE WAS TOLD THAT NO ADDITIONAL INFO WAS AVAILABLE. THIS MDR IS BASED ON THE ATTORNEY NOTICE PROVIDED BY OUR CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRIVE MEDICAL | BATH STOOL | ILS | GENTRY HARDWARE PRODUCTS CO, LTD. | 12004KD-1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 97 YR | Required Intervention |