MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-13 for HU-FRIEDY 7/8 YOUNGER-GOOD CURETTE SYG7/8 manufactured by Hu-friedy Mfg. Co., Llc.
[111002102]
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. Reprocessor does not apply. No concomitant medical products or therapy dates provided.
Patient Sequence No: 1, Text Type: N, H10
[111002103]
It was reported to hu-friedy mfg. Co. , llc that an instrument broke in a patient's mouth during a procedure. The tip became embedded in the gum and the dentist opened a flap to retrieve it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2018-00004 |
| MDR Report Key | 7598883 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-05-14 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2018-06-13 |
| 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 | HU-FRIEDY 7/8 YOUNGER-GOOD CURETTE |
| Generic Name | CURETTE, PERIODONTIC |
| Product Code | EMS |
| Date Received | 2018-06-13 |
| Returned To Mfg | 2018-05-14 |
| Model Number | SYG7/8 |
| Catalog Number | SYG7/8 |
| Lot Number | 0311 |
| 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 | 2018-06-13 |