MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-14 for MINI FIVE GRACEY CURETTE SAS1/271 manufactured by Hu-friedy Mfg. Co. Llc.
[138891227]
Patient weight, ethnicity and race unknown. There is no relevant history. Based on the lot number of the device, this device was produced prior to the udi deadline for class i, therefore udi is not present. 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. Ind is not applicable. Not applicable.
Patient Sequence No: 1, Text Type: N, H10
[138891228]
During a surgical cleaning ((b)(6) 2019) of the furcation area on tooth 46, the tip fractured off and was left in situ. Patient was advised of problem and dentist wanted to see if she healed and tip appeared. It did not, so she returned to office and it was removed surgically on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2019-00005 |
| MDR Report Key | 8423390 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2019-03-14 |
| 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 | DENTIST |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI FIVE GRACEY CURETTE |
| Generic Name | CURETTE, PERIODONTIC |
| Product Code | EMS |
| Date Received | 2019-03-14 |
| Returned To Mfg | 2019-03-05 |
| Model Number | SAS1/271 |
| Catalog Number | SAS1/271 |
| Lot Number | T3 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-03-14 |