MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-25 for BLADE EXTENDED KIT LAR-AE manufactured by Acmi Norwalk.
[760395]
"during a procedure the blade extender came off the blade. " pt coughed up a plastic material that was determined to be the laryngoscope's blade extender.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 965265 |
| MDR Report Key | 965265 |
| Date Received | 2004-08-25 |
| Date of Report | 2004-08-21 |
| Date of Event | 2004-08-05 |
| Date Facility Aware | 2004-08-06 |
| Date Added to Maude | 2007-12-18 |
| 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 |
| 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 | BLADE EXTENDED KIT |
| Generic Name | 500 |
| Product Code | EQN |
| Date Received | 2004-08-25 |
| Model Number | LAR-AE |
| Catalog Number | LAR-AE |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 12 MO |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 934881 |
| Manufacturer | ACMI NORWALK |
| Manufacturer Address | * NORWALK OH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-25 |