FDA.reportPublic FDA data

MAUDE MDR 5944306

MDR report key
5944306
Report number
1416605-2016-00005
Event key
0
Event type
3
Date of event
2016-08-11
Date received
2016-09-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. MARIA VRABIE
Address
3232 N ROCKWELL ST. CHICAGO IL 60618 US
Phone
773-773-7738
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HU-FRIEDYCURETTEHU-FRIEDY MFG. CO., LLCEMSSGY7/89SGY7/890915Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-1201. O; 2. R

Event Narratives#

N

Patient 1

PATIENT IDENTIFIED NOT PROVIDED. THE AGE AT TIME OF EVENT, DATE OF BIRTH ARE UNKNOWN. THE SEX IS UNKNOWN. THE WEIGHT IS UNKNOWN. THERE IS NO RELEVANT HISTORY. HU-FRIEDY DOES NOT TRACK OUR DEVICES (WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES) BY SERIAL NUMBER OR UDI, ONLY BY A LOT NUMBER, WHICH IS TIED TO THE DATE OF MANUFACTURE. 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. REPROCESSOR DOES NOT APPLY. NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES PROVIDED. PMA/510(K) DOES NOT APPLY. IND DOES NOT APPLY.

D

Patient 1

THE DOCTOR WAS USING THE INSTRUMENT DURING A SCALING AND ROOT PLANING PROCEDURE WHEN THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT'S MOUTH. A FLAP IN THE MOUTH WAS OPENED TO REMOVE THE BROKEN TIP.