FDA Adverse Event
Injury
Summary report: N
HU-FRIEDY 15C STERILE SCALPEL BLADE, STAINLESS STEEL
MDR report key: 6655445
·
Received June 20, 2017
Report
- Report Number
- 3009968482-2017-00001
- Event Type
- Injury
- Date Received
- June 20, 2017
- Date of Event
- May 19, 2017
- Report Date
- July 21, 2017
- Manufacturer
- OTTO RUETTGERS GMBH & CO. KG
- Product Code
- GES
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IL, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO HU-FRIEDY MFG. CO., LLC THAT THE DENTIST WAS PERFORMING AN IMPLANT PROCEDURE WHEN THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE PATIENT SWALLOWED THE TIP. THIS FOLLOW-UP REPORT IS TO CORRECT INITIAL REPORT # 3009968482-2017-00001. INITIALLY, IT WAS INCORRECTLY REPORTED THAT THE DEVICE INVOLVED IN THE EVENT HAD BEEN RETURNED TO THE MANUFACTURER. HOWEVER, WHILE OTHER DEVICES FROM THE SAME LOT WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED TO (B)(4) THAT THE DENTIST WAS PERFORMING AN IMPLANT PROCEDURE WHEN THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. THE PATIENT SWALLOWED THE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433688 | HU-FRIEDY 15C STERILE SCALPEL BLADE, STAINLESS STEEL | STERILE SCALPEL BLADE | GES | OTTO RUETTGERS GMBH & CO. KG | 40-815C | 3320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |