MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-08 for ALLEN STIRRUPS (SAM I) SAM I - 0017 10020 manufactured by Allen Medical Systems.
[19702671]
Pt in surgery. Allen stirrups being utilized. Left leg fell down in stirrup for no reason, with no one touching stirrup or pt, while pt anesthetized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 111777 |
| MDR Report Key | 111777 |
| Date Received | 1997-08-08 |
| Date of Report | 1997-08-07 |
| Date of Event | 1997-08-05 |
| Date Facility Aware | 1997-08-05 |
| Report Date | 1997-08-07 |
| Date Reported to FDA | 1997-08-07 |
| Date Reported to Mfgr | 1997-08-07 |
| Date Added to Maude | 1997-08-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEN STIRRUPS (SAM I) |
| Generic Name | PT LEG SUPPORT-OPERATING ROOM |
| Product Code | EYD |
| Date Received | 1997-08-08 |
| Model Number | SAM I - 0017 |
| Catalog Number | 10020 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 109749 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | 15627 NEW PARKWAY GARFIELD HGTS OH 44128 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-08 |