MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-08 for BOSTON UNIVERSITY SUSPENSION * manufactured by Pilling Usa.
[377474]
Suspension broke and pt's head dropped to o. R. Table, which was padded. Procedure (microlaryngoscopy) had been completed, no injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035143 |
| MDR Report Key | 590619 |
| Date Received | 2005-04-11 |
| Date of Report | 2005-03-30 |
| Date of Event | 2005-03-25 |
| Date Added to Maude | 2005-04-14 |
| 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 | BOSTON UNIVERSITY SUSPENSION |
| Generic Name | HEAD SUSPENSION |
| Product Code | EPW |
| Date Received | 2005-04-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 580471 |
| Manufacturer | PILLING USA |
| Manufacturer Address | * * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-11 |