MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-12 for HU-FRIEDY #11/12R CURETTE RIGID SG11/12R9E2 manufactured by Hu-friedy Mfg. Co. Llc.
[123519745]
Weight of patient is unknown. Ethnicity of patient is unknown. Race of patient is unknown. No known relevant tests or laboratory data. No known relevant history. Hu-friedy does not track 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. Preprocessor does not apply. No concomitant medical products or therapy dates provided. Ind does not apply.
Patient Sequence No: 1, Text Type: N, H10
[123519746]
It was reported to hu-friedy that a patient was being treated when the tip of an instrument broke and became lodged in the gum near the mesial of tooth #2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2018-00007 |
| MDR Report Key | 7960256 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-09-18 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2018-10-12 |
| 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 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 | HU-FRIEDY #11/12R CURETTE RIGID |
| Generic Name | CURETTE, PERIODONTIC |
| Product Code | EMS |
| Date Received | 2018-10-12 |
| Returned To Mfg | 2018-09-26 |
| Model Number | SG11/12R9E2 |
| Catalog Number | SG11/12R9E2 |
| Lot Number | 0118 |
| 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 | 2018-10-12 |