MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-06 for AFTER FIVE GRACEY CURETTE SRP13/14R7 manufactured by Hu-friedy Mfg. Co. Llc.
[135231832]
Other relevant history: there is no relevant history. Udi #: based on the lot number the udi requirement does not yet apply. Additionally, we do not use product serialization. Implant date, explant date: the device is not implanted; therefore, implant/explant dates are not applicable. Name and address of reprocessor: reprocessor does not apply. Concomitant medical products: no known concomitant medical products and therapy dates. For use by user facility/importer: not applicable, as we are filing this report as the device manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[135231833]
The tip of a curette broke during non-surgical periodontal therapy. It was being used with normal stroke in the 16-17 interdental area. An x-ray suggested it was stuck in an angular defect and then broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2019-00003 |
| MDR Report Key | 8312699 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-04 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2019-02-06 |
| 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 |
| 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 CURETTE |
| Generic Name | CURETTE, PERIODONTIC |
| Product Code | EMS |
| Date Received | 2019-02-06 |
| Returned To Mfg | 2019-01-30 |
| Model Number | SRP13/14R7 |
| Catalog Number | SRP13/14R7 |
| Lot Number | 0718 |
| 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 | 2019-02-06 |