MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-09 for #152 CUMINE DE SCALER, #6 HD1 SCM1526 manufactured by Hu-friedy Mfg. Co.,llc..
[5090806]
On (b)(6) 2014, during a procedure to remove a tooth, a hu-friedy scaler broke inside the patient's mouth. A foreign object was found in the patient's left maxillary sinus. The patient was hospitalized between (b)(6) 2014. The foreign object was removed through the maxillary sinus via surgery. It was reported that the post surgical process was without complications. A follow up appointment was made to remove the sutures.
Patient Sequence No: 1, Text Type: D, B5
[12363423]
The broken device without the tip was returned to hu-friedy on (b)(4) 2014. The returned device was reviewed and the device appeared to be old and worn. The unbroken working end had a dull cutting edge. The dull condition of the instrument appears to have contributed to applying a force higher than material capability to the working end and consequently resulting in breakage. Additionally, these types of scalers have a normal life expectancy of up to 9 months. This instrument was manufactured in january 2011. Weight and age of patient is not known. Hu-friedy does not track our devices, which are mostly low risk class i devices, by serial number, 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 applicable. The initial reporter's email address is not known. All are not applicable. This is a class i exempt device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2014-00006 |
| MDR Report Key | 4173060 |
| Report Source | 05 |
| Date Received | 2014-10-09 |
| Date of Report | 2014-10-03 |
| Date of Event | 2014-06-16 |
| Date Mfgr Received | 2014-09-16 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2014-10-17 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | #152 CUMINE DE SCALER, #6 HD1 |
| Generic Name | SCALER |
| Product Code | EMN |
| Date Received | 2014-10-09 |
| Returned To Mfg | 2014-09-22 |
| Model Number | SCM1526 |
| Catalog Number | SCM1526 |
| Lot Number | 0111 |
| 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. Hospitalization; 2. Other | 2014-10-09 |