MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-04-10 for BARNHART CURETTE SBH5/69 manufactured by Hu-friedy Mfg. Co., Inc..
[5671619]
The tip of a hu-friedy barnhart curette broke in a pt's mouth during a procedure for scaling and root planing for the maxillary right posterior sextant and local delivery of a chemotherapeutic agent for ailing implant #3. The broken tip was not visible on x-rays taken at the doctor's office. The doctor advised the pt to proceed to the hospital for emergency treatment. The pt was admitted to the hospital and referred to an ent for a scoping procedure. It was reported that the tip was visualized radiographically in the larynx and that the intubation process may have pushed the instrument tip down into the esophagus. While still hospitalized, the pt suffered from a cardiac event. The pt was sent to a secondary facility where a cardiac catheterization, angioplasty and insertion of a cardiac stent was ordered. The dentist office is unable to confirm if the pt received all of the recommended procedures. The dental office is able to confirm that the pt was released and at home by (b)(6) 2015. No further medical procedures or therapies were reported.
Patient Sequence No: 1, Text Type: D, B5
[13197472]
The practice has not returned the broken instrument for hu-friedy to evaluate. Weight of the pt is not known. Hu-friedy does not track our devices, which are mostly low risk class 1 devices, by serial number udi, only a lot which is tied to the date of the mfr. 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 (a) nda, ind, bla, and 510(k) are not applicable to this class i device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2015-00001 |
| MDR Report Key | 4683637 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-04-10 |
| Date of Report | 2017-10-16 |
| Date of Event | 2015-03-10 |
| Date Mfgr Received | 2015-03-11 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2015-04-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | BARNHART CURETTE |
| Generic Name | 5/6 BARNHART CURETTE, EVEREDGE |
| Product Code | EMS |
| Date Received | 2015-04-10 |
| Returned To Mfg | 2016-05-07 |
| Model Number | SBH5/69 |
| Catalog Number | SBH5/69 |
| Lot Number | 06/2013 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., INC. |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-04-10 |