FDA Adverse Event
Injury
Summary report: N
HENRY SCHEIN
MDR report key: 19381231
·
Received May 23, 2024
Report
- Report Number
- 2411236-2024-00007
- Event Type
- Injury
- Date Received
- May 23, 2024
- Date of Event
- February 27, 2024
- Report Date
- May 23, 2024
- Manufacturer
- PRIMA DENTAL GROUP
- Product Code
- EJL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A DOCTOR WAS PERFORMING A MOUTH EXTRACTION PROCEDURE ON A 62 YEAR OLD MALE PATIENT WHEN THE BUR CAME OUT OF A SURGICAL HANDPIECE AND WENT DOWN THEIR THROAT AND WAS SWALLOWED. THE DOCTOR ADVISED THAT THE PATIENT ATTEMPTED TO COUGH AND MAKE THEMSELVES THROW UP BUT WAS UNSUCCESSFUL. THE PATIENT WAS GIVEN A REFERRAL TO AN URGENT CARE FACILITY AND WERE SAID TO HAVE TO COME BACK TO THE DOCTOR'S PRACTICE ON (B)(6) 2024 FOR A POST OP. IT WAS CONFIRMED THAT THE PATIENT DID GO TO THE URGENT CARE FACILITY FOR AN XRAY. NO OTHER INFORMATION WAS MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584277 | HENRY SCHEIN | SURGICAL BUR FG 557 | EJL | PRIMA DENTAL GROUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Other |