FDA Adverse Event
Injury
Summary report: N
BASIC X-TRA TRACTION SHOE COVER
MDR report key: 618040
·
Received June 29, 2005
Report
- Report Number
- 9616096-2005-00041
- Event Type
- Injury
- Date Received
- June 29, 2005
- Date of Event
- June 2, 2005
- Report Date
- June 29, 2005
- Manufacturer
- KIMBERLY-CLARK CORP.
- Product Code
- FXP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AN INDIVIDUAL WAS WEARING THE SHOE COVER AND THE FLOOR WAS DRY AND HAD BEEN WAXED ONE WEEK EARLIER. THE INDIVIDUAL FELL AND REQUIRED KNEE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASIC X-TRA TRACTION SHOE COVER | SHOE COVER | FXP | KIMBERLY-CLARK CORP. | NA | UNAVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization |