MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-02-27 for HU-FRIEDY E301 manufactured by Hu-friedy Manufacturing.
[253643]
During the course of attempting to extract tooth #16 on the patient, the dentist broke off the cap of patients wisdom tooth lacerating the toungue and piercing the floor of the patients mouth approximately 3mm with a sharp dental instrument which has been identified to be an e301 elevator. The patient began to bleed profusely and a sublinqual hematoma formed which obstructed the patient's airway. The patient was hospitalized where an emergency tracheostomy was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2002-00001 |
| MDR Report Key | 379294 |
| Report Source | 00 |
| Date Received | 2002-02-27 |
| Date of Report | 2002-02-26 |
| Date of Event | 2000-10-09 |
| Date Mfgr Received | 2002-01-25 |
| Date Added to Maude | 2002-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KEITH DUNN, DIRECTOR |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7739756100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY |
| Generic Name | ELEVATOR |
| Product Code | EMN |
| Date Received | 2002-02-27 |
| Model Number | E301 |
| Catalog Number | E301 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 368327 |
| Manufacturer | HU-FRIEDY MANUFACTURING |
| Manufacturer Address | 3232 NORTH ROCKWELL ST. CHICAGO IL 60618 US |
| Baseline Brand Name | HU-FRIEDY |
| Baseline Generic Name | ELEVATOR |
| Baseline Model No | E301 |
| Baseline Catalog No | E301 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2002-02-27 |