FDA Adverse Event
Injury
Summary report: N
SACH FOOT FOR MEN -LIGHTWEIGHT
MDR report key: 315220
·
Received February 8, 2001
Report
- Report Number
- 2182293-2001-00001
- Event Type
- Injury
- Date Received
- February 8, 2001
- Date of Event
- December 19, 2000
- Report Date
- February 7, 2001
- Manufacturer
- OTTO BOCK ORTHOPADISCHE INDUSTRIE, GMBH
- Product Code
- ISH
- Removal / Correction Number
- 2182293-2001-0001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON JANUARY 16, 2001 OTTO BOCK RECEIVED A CALL FROM ONE OF THE CO'S SALES REPS. HE REPORTED THAT ONE OF THE CO'S CUSTOMERS CALLED TO REPLACE A STOCK OF 1S57 FEET WITH A HEAVIER, STRONGER FOOT. WHEN HE INQUIRED AS TO WHY THEY WANTED TO DO THIS, THE CUSTOMER MENTIONED THAT A PT HAD FALLEN AND BROKEN THEIR FEMUR. THE CO HAS NO FURTHER INFO BECAUSE THE PT WILL NOT TALK ABOUT THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4722 | SACH FOOT FOR MEN -LIGHTWEIGHT | PROSTHETIC FOOT | ISH | OTTO BOCK ORTHOPADISCHE INDUSTRIE, GMBH | 1S57 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | N/K |