MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-05 for ALLEN STIRRUP SYSTEM 10020-G * manufactured by Allen Medical Systems, Inc..
[121433]
During surgery, the physician noted some movement of the pt's left leg in the stirrup. The nurse checked the boot and found it loose. The nurse continued to hold or support the boot leg during surgery. While holding the boot it became completely detached from the stirrup pole at the welded site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014323 |
| MDR Report Key | 180944 |
| Date Received | 1998-08-05 |
| Date of Report | 1998-07-28 |
| Date of Event | 1998-07-14 |
| Date Added to Maude | 1998-08-10 |
| 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 |
| 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 STIRRUP SYSTEM |
| Generic Name | STIRRUP BOOT |
| Product Code | EYD |
| Date Received | 1998-08-05 |
| Model Number | 10020-G |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 175960 |
| Manufacturer | ALLEN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 15627 NEO PKWY. CLEVELAND OH 44128 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-08-05 |