FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 2926229
·
Received January 17, 2013
Report
- Report Number
- 2438477-2013-00004
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- June 9, 2012
- Report Date
- November 16, 2012
- Manufacturer
- UNKNOWN
- Product Code
- INM
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
(B)(4) HAS RECEIVED AN ATTORNEY LETTER AND A NOTICE OF POSSIBLE CLAIM FROM A LAW FIRM ABOUT AN INCIDENT INVOLVING A SHOWER CHAIR ALLEGEDLY IMPORTED AND DISTRIBUTED BY (B)(4). THE ATTORNEY STATED THAT THE CLAIMANT WAS A GUEST AT A HOTEL IN (B)(6). WHEN HE ATTEMPTED TO USE THE SHOWER CHAIR PROVIDE BY THE HOTEL, THE CHAIR COLLAPSED CAUSING HIM TO FALL AND SUSTAIN SERIOUS INJURIES. DRIVE MEDICAL HAD REACHED OUT TO THE ATTORNEY OFFICE INVESTIGATE THE INCIDENT. ALLEGEDLY THE CLAIMANT RECEIVED A COMPRESSION FRACTURE ON HIS TAILBONE WITH BRUISES AND BUMPS. THIS MDR REPORT IS BASED ON THE INFORMATION PROVIDED BY CLAIMANT'S ATTORNEY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26164 | DRIVE MEDICAL | SHOWER CHAIR | INM | UNKNOWN | UNKNOWN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |