MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-02-11 for HU-FRIEDY SCALER DE H6/H7 8HDL manufactured by Hu-friedy Mfg. Co., Llc.
[4567466]
During a dental procedure involving a routine cleaning and taking impressions for a partial, the tip of a scaler broke off in the patient's mouth. After the procedure, x-rays were taken and it was determined that the tip was in the patient's stomach. Surgery was conducted and the tip was successfully removed from the patient's stomach. All events occurred on (b)(6) 2013. The above events were described to hu-friedy by the initial reporter on (b)(6) 2014. Hu-friedy could not confirm the accuracy of these events or if it was their instrument involved in these events.
Patient Sequence No: 1, Text Type: D, B5
[12081401]
Information provided could not be confirmed because the instrument was not returned. All remaining n/a in this section are not known because the instrument was not returned to hu-friedy. This is a class i exempt device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2014-00001 |
| MDR Report Key | 3865213 |
| Report Source | 06 |
| Date Received | 2014-02-11 |
| Date of Report | 2014-02-07 |
| Date of Event | 2013-02-19 |
| Date Mfgr Received | 2014-01-23 |
| Date Added to Maude | 2014-06-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA VRABLE, DIRECTOR |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7738685676 |
| Manufacturer G1 | HU-FRIEDY MFG. CO.,INC. |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60618 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY SCALER DE H6/H7 8HDL |
| Generic Name | PERIODONTAL SCALER |
| Product Code | EMN |
| Date Received | 2014-02-11 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | 3232 NORTH ROCKWELL ST. CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-11 |