MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-12 for HU-FRIEDY SGY7/89 manufactured by Hu-friedy Mfg. Co., Llc.
[54894446]
Patient identified not provided. The age at time of event, date of birth are unknown. The sex is unknown. The weight is unknown. 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 was a stainless steel instrument that does not have an expiration date. The device is not implanted; therefore implant/explant dates are not applicable. Reprocessor does not apply. No concomitant medical products and therapy dates provided. Pma/510(k) does not apply. Ind does not apply.
Patient Sequence No: 1, Text Type: N, H10
[54894447]
The doctor was using the instrument during a scaling and root planing procedure when the tip of the instrument broke in the patient's mouth. A flap in the mouth was opened to remove the broken tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2016-00005 |
| MDR Report Key | 5944306 |
| Date Received | 2016-09-12 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-08-11 |
| Date Mfgr Received | 2016-08-11 |
| Date Added to Maude | 2016-09-12 |
| 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 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 | 0 |
| Brand Name | HU-FRIEDY |
| Generic Name | CURETTE |
| Product Code | EMS |
| Date Received | 2016-09-12 |
| Returned To Mfg | 2016-08-26 |
| Model Number | SGY7/89 |
| Catalog Number | SGY7/89 |
| Lot Number | 0915 |
| Operator | DENTIST |
| 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; 2. Required No Informationntervention | 2016-09-12 |