MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-30 for HU-FRIEDY 5-68 BARNHART CURETTE, RESINEIGHT SBH5/68 manufactured by Hu-friedy Mfg. Co., Llc.
[20733790]
Curette with a resin handle broke off at shank prior to scaling procedures, while doing some exploring within the mouth. An ambulance was called and the pt was transported to the local hospital and went to the emergency room. The broken tip was removed from the gi tract by a endoscopic procedure. Pt is doing fine, no additional medical procedures or treatment needed.
Patient Sequence No: 1, Text Type: D, B5
[20905695]
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. The product involved in the event was a stainless steel instrument that does not have a expiration date. The device is not implanted, therefore implant/explant dates are not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2011-00002 |
| MDR Report Key | 2278797 |
| Report Source | 06 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-09-30 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2011-09-02 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-07-06 |
| 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 N ROCKWELL ST |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY 5-68 BARNHART CURETTE, RESINEIGHT |
| Generic Name | SBH5-68 |
| Product Code | EKE |
| Date Received | 2011-09-30 |
| Returned To Mfg | 2011-09-23 |
| Model Number | SBH5/68 |
| Catalog Number | SBH5/68 |
| Lot Number | U11 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-09-30 |