FDA Adverse Event
Malfunction
Summary report: Y
MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
MDR report key: 16781288
·
Received April 20, 2023
Report
- Report Number
- 9614977-2023-00008
- Event Type
- Malfunction
- Date Received
- April 20, 2023
- Report Date
- December 7, 2023
- Manufacturer
- SIRONA DENTAL SYSTEMS GMBH
- Product Code
- EFB
- PMA / PMN Number
- K192409
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
EVENTS WERE SUBMITTED UNDER INDIVIDUAL REPORT NUMBERS 9614977-2023-00043 AND 9614977-2023-00044. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION.
Additional Manufacturer Narrative · 0
2 OF 2 DEVICES WERE RETURNED FOR EVALUATION. EVALUATION OF 2 DEVICES FOUND NORMAL CHUCK WEAR AND THE TURBINE NEEDED TO BE REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Additional Manufacturer Narrative · 0
EVENTS ARE NOT ELIGIBLE FOR SUMMARY REPORT. THESE WILL BE SUBMITTED INDIVIDUALLY.
Additional Manufacturer Narrative · 0
THIS IS A FOLLOW UP REPORT TO CORRECT INFORMATION THAT WAS REPORTED IN THE INITIAL REPORT. CORRECTING PRODUCT CODE FROM EGS TO EFB. CORRECTING 510K NUMBER FROM K792445 TO K192409.
Description of Event or Problem · 0
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS WHERE MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH WOULD NOT HOLD BURS. NO INJURY RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1099248 | MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH | HANDPIECE, AIR-POWERED, DENTAL | EFB | SIRONA DENTAL SYSTEMS GMBH | |||
| 1156850 | MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH | HANDPIECE, AIR-POWERED, DENTAL | EFB | SIRONA DENTAL SYSTEMS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |