MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-10 for AFTER FIVE GRACEY SRP15/16R9 manufactured by Hu-friedy Mfg. Co. Llc.
[132774389]
Date of event is unknown. There are no relevant tests/laboratory data. There is no relevant history. This is a class i device and based on the lot number the udi requirement does not yet apply. Additionally, we do not use product serialization. The device is not implanted, therefore implant/explant dates are not applicable. No known concomitant medical products and therapy dates.
Patient Sequence No: 1, Text Type: N, H10
[132774390]
During a scaling and root planing procedure, the instrument tip broke subgingivally in a patient's mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2019-00001 |
| MDR Report Key | 8236343 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-10 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2019-01-10 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFTER FIVE GRACEY |
| Generic Name | CURETTE, PERIODONTIC |
| Product Code | EMS |
| Date Received | 2019-01-10 |
| Model Number | SRP15/16R9 |
| Catalog Number | SRP15/16R9 |
| Lot Number | 0615 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-01-10 |