FDA Adverse Event
Injury
Summary report: N
ACORN 180 T565
MDR report key: 16119363
·
Received January 8, 2023
Report
- Report Number
- 3003124453-2023-00002
- Event Type
- Injury
- Date Received
- January 8, 2023
- Date of Event
- December 11, 2022
- Report Date
- January 7, 2023
- Manufacturer
- ACORN STAIRLIFTS, INC.
- Product Code
- PCD
- PMA / PMN Number
- N/A#S-P#N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INCIDENT INVESTIGATION REPORT. WORK COMPLETION REPORT.
Description of Event or Problem · 0
CLIENT CONTACTED ACORN STAIRLIFTS, INC. (ACORN) ON (B)(6) 2022. THE CLIENT COMMUNICATED THAT HER HUSBAND WAS WALKING UP THE STAIRS AND HAD FALLEN ON (B)(6) 2022 RESULTING IN THREE BROKEN RIBS ON HIS LEFT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1392462 | ACORN 180 T565 | POWERED STAIRWAY CHAIR LIFT | PCD | ACORN STAIRLIFTS, INC. | 180 T565 RH USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | Other |