MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-12-21 for HU-FRIEDY 9/10 GRACEY CURETTE SG9/10C8 manufactured by Hu-friedy Mfg. Co., Llc.
[95591821]
Ethnicity of patient is unknown. 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 does not have an expiration date. The device is not implanted, therefore implant/explant dates are not applicable. Reprocessor does not apply. No known concomitant medical products and therapy dates.
Patient Sequence No: 1, Text Type: N, H10
[95591822]
During a procedure, the shank of the device broke at the shank in the patient's mouth and cut his lip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2017-00006 |
| MDR Report Key | 7140223 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2017-12-21 |
| 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 | 7738685537 |
| 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 9/10 GRACEY CURETTE |
| Generic Name | CURETTE, PERIODONTIC |
| Product Code | EMS |
| Date Received | 2017-12-21 |
| Returned To Mfg | 2017-12-11 |
| Model Number | SG9/10C8 |
| Catalog Number | SG9/10C8 |
| Lot Number | 0515 |
| 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 | 2017-12-21 |