MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,08 report with the FDA on 2001-02-08 for SACH FOOT FOR MEN -LIGHTWEIGHT 1S57 NA manufactured by Otto Bock Orthopadische Industrie, Gmbh.
[22076389]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182293-2001-00001 |
| MDR Report Key | 315220 |
| Report Source | 04,05,08 |
| Date Received | 2001-02-08 |
| Date of Report | 2001-02-07 |
| Date of Event | 2000-12-19 |
| Date Facility Aware | 2001-01-16 |
| Report Date | 2001-02-07 |
| Date Reported to FDA | 2001-02-07 |
| Date Reported to Mfgr | 2001-02-09 |
| Date Added to Maude | 2001-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3000 XENIUM LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 8003284058 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 2182293-2001-0001 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SACH FOOT FOR MEN -LIGHTWEIGHT |
| Generic Name | PROSTHETIC FOOT |
| Product Code | ISH |
| Date Received | 2001-02-08 |
| Model Number | 1S57 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 304821 |
| Manufacturer | OTTO BOCK ORTHOPADISCHE INDUSTRIE, GMBH |
| Manufacturer Address | MAX-NADER - STR. 115 DUDERSTADT GM D-37115 |
| Baseline Brand Name | SACH FOOT |
| Baseline Generic Name | PROSTHETIC FOOT |
| Baseline Model No | 1S57 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | PROSTHETIC COMPONENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-02-08 |