FDA Adverse Event
Injury
Summary report: N
HANDICARE 1100
MDR report key: 17837366
·
Received September 28, 2023
Report
- Report Number
- 1041130-2023-00003
- Event Type
- Injury
- Date Received
- September 28, 2023
- Date of Event
- August 9, 2023
- Report Date
- September 27, 2023
- Manufacturer
- HANDICARE STAIRLIFTS B.V.
- Product Code
- PCD
- UDI-DI
- 8719326254326
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
UNIT WAS INSPECTED ON SITE. RAIL WAS VERY WELL LUBRICATED, AN INDICATION THAT ADDITIONAL LUBRICANT WAS APPLIED BY END USER. THE ENTIRE SYSTEM (SEAT CONNECTED TO THE RAIL) WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION.
Description of Event or Problem · 0
CUSTOMER (72) WAS ATTEMPTING TO SIT ON THE UNIT, AND POWERPACK/CHAIR SLIDE DOWN THE RAIL, EJECTING CUSTOMER. BROTHER DOWNSTAIRS CALLED AN AMBULANCE TO GO TO HOSPITAL. CUSTOMER HAD CUTS/BRUISES. NO INTERNAL BLEEDING/BROKEN BONES. MAJOR BRUISING/SWELLING ON BACK, BAD SHOULDER, BUT IS HEALING UP. CUSTOMER WAS IN HOSPITAL FOR 2 DAYS THEN ADMITTED TO REHAB FOR 2 WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2246430 | HANDICARE 1100 | STAIR CHAIR LIFT | PCD | HANDICARE STAIRLIFTS B.V. | 1100 | 8719326254326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Hospitalization |