MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-25 for ALLEN MEDICAL SYSTEMS 10023 * manufactured by Allen Medical Systems.
[237128]
Pt was in operating room. The hydraulic stirup was laying on the floor. When pt was installing on table, left ring and index fingers got caught in the upper portion of the stirup. The stirup could not be removed easily, so pt was taken to the emergency room. The stirup was removed and pt was sent for physical therapy follow-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023208 |
| MDR Report Key | 358334 |
| Date Received | 2001-10-25 |
| Date of Report | 2001-10-25 |
| Date of Event | 2000-01-05 |
| Date Added to Maude | 2001-10-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEN MEDICAL SYSTEMS |
| Generic Name | GYN STIRRUP |
| Product Code | EYD |
| Date Received | 2001-10-25 |
| Model Number | 10023 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 347529 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | ONE POST OFFICE SQUARE ACTON MA 01720 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2001-10-25 |