MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-22 for GRACEY CURETTE SG13/149E2 manufactured by Hu-friedy Mfg. Co. Llc.
[142632912]
Patient age, weight, ethnicity and race unknown. Based on the lot number of the device, this device was produced prior to the udi deadline for class 1 devices, therefore udi is not present. The device is not implanted, therefore implant/explant dates are not applicable. No known concomitant medical products and therapy dates.
Patient Sequence No: 1, Text Type: N, H10
[142632913]
While the hygienist was scaling with sg13/149e2, the tip broke off the instrument. It was believed that the patient swallowed the tip. Patient was sent to an outpatient imaging center for an x-ray. No follow up was reported at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2019-00007 |
| MDR Report Key | 8535976 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2019-04-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | GRACEY CURETTE |
| Generic Name | CURETTE, PERIODONTIC |
| Product Code | EMS |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-04-08 |
| Model Number | SG13/149E2 |
| Catalog Number | SG13/149E2 |
| Lot Number | 615 |
| 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 | 2019-04-22 |