MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-07 for CURRETTE SG1/26 manufactured by Hu-friedy.
[79752567]
Shank of anterior currette broke when activating on the lingual of #26. I heard a "pop" noise and saw the portion of the currette on the distal of soft palate. I instructed pt not to swallow and attempted to use hve to remove. I lost sight of the currette tip, immediately set pt up in the chair and got the doctor. Pt did not detect any foreign object in his mouth. He was coughing to attempt to cough it out. Checked trap and it was clean. Pt was instructed to have chest x-ray with his physician. He was advised there is a concern if the instrument tip entered his airway/lungs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070886 |
| MDR Report Key | 6700764 |
| Date Received | 2017-07-07 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-06-30 |
| Date Added to Maude | 2017-07-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CURRETTE |
| Generic Name | CURRETTE |
| Product Code | HTF |
| Date Received | 2017-07-07 |
| Returned To Mfg | 2017-07-07 |
| Model Number | SG1/26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY |
| Manufacturer Address | CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-07 |