FDA Adverse Event
Injury
Summary report: N
PROBASICS
MDR report key: 17443967
·
Received August 2, 2023
Report
- Report Number
- 3012316249-2023-00028
- Event Type
- Injury
- Date Received
- August 2, 2023
- Date of Event
- June 2, 2023
- Report Date
- August 2, 2023
- Manufacturer
- JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
- Product Code
- IMM
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PATIENT ATTEMPTED TO AMBULATE AND GOT HER FEET CAUGHT IN THE FOOTREST OF THE WHEELCHAIR FALLING FORWARD RESULTING IN PELVIC FRACTURE REQUIRING SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1467468 | PROBASICS | K2 WHEELCHAIR, 18X16 W/SAFR | IMM | JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. | WC21816DS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Female | Required Intervention| H |