HU-FRIEDY
Received Aug 11, 2016
Report 1416605-2016-00004 · MDR key 5870336
Device
Generic name
Orthodontic Cutter, Product Code: Ekd
Manufacturer
Hu-friedy Mfg. Co. LlcModel number
678-101Catalog number
678-101
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IN A LETTER TO HU-FRIEDY, THE DOCTOR CLAIMED A PATIENT HAD TO BE SENT TO AN ORAL SURGEON BECAUSE ORTHODONTIC WIRE WAS LODGED IN THEIR CHEEK TISSUE. THE DOCTOR INDICATED THAT THE DEVICE USED WAS DISPOSED OF, SO HU-FRIEDY WAS UNABLE TO OBTAIN THE DEVICE FOR EXAMINATION. INITIAL ATTEMPTS BY HU-FRIEDY TO CONTACT THE DOCTOR WERE UNSUCCESSFUL. HU-FRIEDY HAS SO FAR BEEN UNABLE TO VERBALLY CONFIRM THE CLAIMS IN THE LETTER THAT WAS RECEIVED. PATIENT INFORMATION CURRENTLY UNKNOWN. DATE OF EVENT CURRENTLY UNKNOWN. ANY TESTS THAT MAY HAVE BEEN PERFORMED ARE CURRENTLY UNKNOWN. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITION, IS CURRENTLY UNKNOWN. LOT NUMBER UNKNOWN BECAUSE DEVICE INVOLVED IN EVENT WAS DISPOSED OF; EXPIRATION DATE NOT APPLICABLE FOR THIS TYPE OF INSTRUMENT; UDI NUMBER NOT APPLICABLE. EMAIL ADDRESS AND FAX NUMBER OF INITIAL REPORTER UNKNOWN.
Description of Event or Problem
DURING A DENTAL PROCEDURE USING AN ORTHODONTIC CUTTER, WIRE BECAME STUCK IN PATIENT'S CHEEK. PATIENT WENT TO ORAL SURGEON TO HAVE THE WIRE REMOVED.