MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-28 for * L500000 manufactured by Allen Medical Systems.
[18530568]
When patient was waking from anesthesia he moved his leg while still in the lithotomy position, and pulled the stirrup and clamp off the or table. Patient was not injured. Clamp was not holding stirrup firmly. Clamp will be sent back to the company. ======================manufacturer response for allen stirrup clamp, (brand not provided) (per site reporter)======================they will inspect the clamp when it is received and advise if the clamp was faulty or if it was not used properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2894040 |
| MDR Report Key | 2894040 |
| Date Received | 2012-12-28 |
| Date of Report | 2012-12-28 |
| Date of Event | 2012-12-27 |
| Report Date | 2012-12-28 |
| Date Reported to FDA | 2012-12-28 |
| Date Added to Maude | 2013-01-03 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | * |
| Generic Name | TABEL AND ATTACHMENTS |
| Product Code | BWN |
| Date Received | 2012-12-28 |
| Model Number | L500000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | 1 POST OFFICE SQUARE ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-28 |