MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-04 for 5/6 BARNHART CURETTE, EVEREDGE SBH5/69 manufactured by Hu-friedy Mfg. Co., Llc.
[1780254]
During a regularly scheduled dental cleaning with dental hygienist, the curette broke at the shaft and the pt swallowed approx 11mm of the working end of the instrument. The doctor's office gave the pt the remainder of the broken instrument, so that he could take the instrument to the hospital with him. The pt went to the emergency room with the remaining instrument and indicated that he had swallowed the end of the instrument. The pt was x-rayed and the instrument was found inside the pt, in order to make sure that the instrument passed without complications, the hospital kept the pt for observation for 2 days. When the instrument passed on the 2nd day, the pt was released from the hospital and scheduled for a follow-up visit.
Patient Sequence No: 1, Text Type: D, B5
[8870546]
Weight of pt is not known, office was not able to provide the info. Hu- friedy does not track our devices, which are mostly low risk class 1 devices, by serial number, only a lot # which is tied to the date of manufacture. Since the instrument was not returned, we were not able to determinate the lot number. The product involved in the event was a stainless steel instrument that does not have an expiration date. The device is not implanted, therefore, implant/explant dates are not applicable. Since the device was not returned, all evaluation codes were marked n/a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2010-00005 |
| MDR Report Key | 1960225 |
| Report Source | 05,06 |
| Date Received | 2011-01-04 |
| Date of Report | 2010-12-20 |
| Date of Event | 2010-11-18 |
| Date Mfgr Received | 2010-11-22 |
| Date Added to Maude | 2012-03-14 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MARIA VRABIE, TEAM LEADER |
| Manufacturer Street | 3232 NORTH ROCKWELL ST. |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7739753975 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5/6 BARNHART CURETTE, EVEREDGE |
| Generic Name | SBH5/69 |
| Product Code | EMS |
| Date Received | 2011-01-04 |
| Model Number | SBH5/69 |
| Catalog Number | SBH5/69 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY MFG. CO., LLC |
| Manufacturer Address | CHICAGO IL 60618 US 60618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-04 |