FDA Adverse Event
Injury
Summary report: N
MBT FOOTWEAR
MDR report key: 2546138
·
Received April 18, 2012
Report
- Report Number
- 3009089619-2012-00003
- Event Type
- Injury
- Date Received
- April 18, 2012
- Date of Event
- January 21, 2012
- Manufacturer
- MASAI MARKETING + TRADING AG
- Product Code
- KNP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
SHE WAS WALKING DOWN A STEP AND SLIPPED FORWARD. SHE FELL FORWARD AND SIDEWAYS. SHE HAD "EXCRUCIATING PAIN" AND HER FOOT WAS POINTING THE WRONG WAY. SHE MANUALLY PUT HER ANKLE BACK IN PLACE AND SOUGHT MEDICAL HELP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MBT FOOTWEAR | ORTHOSE, CORRECTIVE SHOE | KNP | MASAI MARKETING + TRADING AG | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention| S |