MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-21 for HU-FRIEDY METZENBAUM PERMASHARP SCISSORS S5069 manufactured by Hu-friedy Mfg. Co., Llc.
[80751439]
There is no relevant history. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80751440]
It was reported to hu-friedy mfg. (b)(6) that during an oral surgery procedure, the instrument broke in the patient's mouth. The broken tip was swallowed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416605-2017-00004 |
| MDR Report Key | 6734390 |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-06-15 |
| Date Mfgr Received | 2017-06-15 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2017-07-21 |
| 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 |
| 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 | 0 |
| Brand Name | HU-FRIEDY METZENBAUM PERMASHARP SCISSORS |
| Generic Name | SCISSORS, SURGICAL TISSUE, DENTAL |
| Product Code | EGN |
| Date Received | 2017-07-21 |
| Returned To Mfg | 2017-06-27 |
| Model Number | S5069 |
| Catalog Number | S5069 |
| Lot Number | 0415 |
| 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 | 2017-07-21 |