MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-27 for HU-FRIEDY #0/00 MORSE DE SCALER RESIN PURPLE SM0/00C8 manufactured by Hu-friedy Mfg. Co., Llc.
[22140925]
On (b)(6) 2014, during a dental procedure, the tip of the instrument broke in the patient's gingiva. The broken tip was successfully removed by opening the gingiva.
Patient Sequence No: 1, Text Type: D, B5
[22306515]
The device was returned to hu-friedy on (b)(4) 2014. The returned instrument was reviewed and it was determined that the returned instrument appears to have broken by applying a force higher than material capability to the working end and consequently resulting in breakage. Section a- weight sex, and age of patient is not known. Section d- hu-friedy does not track our devices, which are mostly low risk class i devices, by serial number, udi#, only a lot # 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 known. Section g, #5 all are not applicable. This is a class i exempt device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2014-00005 |
| MDR Report Key | 3905051 |
| Report Source | 06 |
| Date Received | 2014-05-27 |
| Date of Report | 2014-05-19 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-05-06 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2014-07-15 |
| 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 VRABIE, DIRECTOR OF RA |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7738685676 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY #0/00 MORSE DE SCALER RESIN PURPLE |
| Generic Name | PERIODONTAL SCALER |
| Product Code | EMN |
| Date Received | 2014-05-27 |
| Returned To Mfg | 2014-05-09 |
| Model Number | SM0/00C8 |
| Catalog Number | SM0/00C8 |
| Lot Number | 0114 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-05-27 |