MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-03 for BULLARD LARS-A ELITE LAR-ER manufactured by Circon Acmi.
[19245158]
Pt had difficult airway and a bullard laryngoscope with a plastic blade extension was used. It is believed that the plastic extension was not secured to the bullard. Pt had symptoms of pain in their throat and awoke in the middle of the night at home feeling unable to breathe. The pt's spouse called 9-1-1 then slapped pt on the back. When slapped on the back the pt coughed up the plastic extender tip and was okay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034860 |
| MDR Report Key | 579867 |
| Date Received | 2005-03-03 |
| Date of Report | 2005-03-03 |
| Date of Event | 2005-01-20 |
| Date Added to Maude | 2005-03-11 |
| 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 | BULLARD |
| Generic Name | FIBEROPTIC LARYNGOSCOPE |
| Product Code | EQN |
| Date Received | 2005-03-03 |
| Model Number | LARS-A ELITE |
| Catalog Number | LAR-ER |
| Lot Number | 1402734L |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 569714 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 138 TURNPIKE RD. SOUTHBOROUGH MA 01772 US |
| Baseline Brand Name | BLADE EXTENDER FOR BULLARD LARYNGOSCOPE |
| Baseline Generic Name | LARYNGOSCOPE |
| Baseline Model No | LAR-AE |
| Baseline Catalog No | LAR-AE |
| Baseline ID | NA |
| Baseline Device Family | LARYNGOSCOPE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K883819 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-03 |