MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-30 for BULLARD ADULT BULLARD ELITE WITH INTRODUCING STYLET KIT LARS-A manufactured by Acmi Corp..
[21613172]
A trauma patient complained of a sore throat after a nasal fracture reduction procedure. Examination of the patient revealed that a plastic laryngoscope blade extender tip had been left within the patient when the laryngoscope was removed. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 898197 |
| MDR Report Key | 898197 |
| Date Received | 2007-05-30 |
| Date of Report | 2007-05-30 |
| Date of Event | 2007-05-02 |
| Report Date | 2007-05-30 |
| Date Reported to FDA | 2007-05-30 |
| Date Added to Maude | 2007-08-20 |
| 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 | 0 |
| 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 |
| Product Code | EQN |
| Date Received | 2007-05-30 |
| Model Number | ADULT BULLARD ELITE WITH INTRODUCING STYLET KIT |
| Catalog Number | LARS-A |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 874651 |
| Manufacturer | ACMI CORP. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-30 |