MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-08 for BULLARD ADULT BULLARD ELITE WITH INTRODUCING LARS-A manufactured by Acmi Corp.
[15490753]
A pt complained of a sore throat after a surgical procedure that included the use of an acmi bullard lars-a laryngoscope. Examination of the pt revealed that a plastic laryngoscope blade extender had been left within the pt when the laryngoscope was removed. Close examination of the laryngoscope revealed that the plastic extender can be difficult to attach and if not properly attached, can unintentionally become disconnected from the device. Anesthesiologists investigating the incident indicated an awareness of this problem having occurred before, both at this institution and elsewhere. This device is still in use at the facility and they will contact the mfr, at the request of the fda, to come on site and evaluate the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 515460 |
| MDR Report Key | 515460 |
| Date Received | 2004-03-08 |
| Date of Report | 2004-02-01 |
| Date of Event | 2004-01-01 |
| Date Added to Maude | 2004-03-15 |
| 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 | BULLARD |
| Generic Name | LARYNGOSCOPE WITH DISPOSABLE EXTENDER |
| Product Code | EQN |
| Date Received | 2004-03-08 |
| Model Number | ADULT BULLARD ELITE WITH INTRODUCING |
| Catalog Number | LARS-A |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 504468 |
| Manufacturer | ACMI CORP |
| Manufacturer Address | 93 NORTH PLEASANT ST NORWALK OH 44857 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-03-08 |