MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-19 for ALLEN STIRRUP * ALS 6200 manufactured by Valley Tech.
[416686]
Patient had been placed in allen stirrups for a procedure. As the nurse was preparing with the surgical prep, she heard a snap. The stirrup fell to the floor. It appears that the spot weld holding the boot to the stem gave way. No apparent injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037443 |
| MDR Report Key | 660988 |
| Date Received | 2005-12-19 |
| Date of Report | 2005-11-10 |
| Date of Event | 2005-10-28 |
| Date Added to Maude | 2006-01-10 |
| 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 | 3 |
| 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 STIRRUP |
| Generic Name | ALLEN STIRRUP |
| Product Code | EYD |
| Date Received | 2005-12-19 |
| Returned To Mfg | 2005-11-11 |
| Model Number | * |
| Catalog Number | ALS 6200 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 650409 |
| Manufacturer | VALLEY TECH |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-19 |