MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-07-21 for HU-FRIEDY 1/2 GRACEY CURETTE SG1/26 manufactured by Hu-friedy Mfg. Co., Llc.
[80752657]
There are no relevant tests/laboratory data. There is no relevant history. Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number or udi, only by a lot number, which is tied to the date of manufacture. The product involved in the event does not have an expiration date. The device is not implanted, therefore implant/explant dates are not applicable. Reprocessor does not apply. No known concomitant medical products and therapy dates. User facility/importer does not apply. Pma/510(k) is not applicable. Ind is not applicable.
Patient Sequence No: 1, Text Type: N, H10
[80752658]
It was reported to hu-friedy mfg. Co. , llc that during a dental cleaning procedure, the instrument broke in the patient's mouth. Retrieval of the tip was attempted using suction. It is unknown whether or not the tip was swallowed by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2017-00003 |
| MDR Report Key | 6733466 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-07-08 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2017-07-21 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARIA VRABIE |
| Manufacturer Street | 3232 N ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7738685676 |
| Manufacturer G1 | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Street | 3232 N. ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60618 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY 1/2 GRACEY CURETTE |
| Generic Name | CURETTE, PERIODONTIC |
| Product Code | EMS |
| Date Received | 2017-07-21 |
| Returned To Mfg | 2017-07-11 |
| Model Number | SG1/26 |
| Catalog Number | SG1/26 |
| Lot Number | 0414 |
| Operator | DENTAL HYGIENIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | 3232 N. ROCKWELL ST. CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-21 |