FDA.reportPublic FDA data

MAUDE MDR 3561869

MDR report key
3561869
Report number
1925223-2014-00003
Event key
0
Event type
3
Date received
2014-01-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. AUDI BOGUCKI
Address
300 HERAEUS WAY SOUTH BEND IN 46614 US
Phone
574-574-5742
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IVORY CLAMPCLAMP, RUBBER DAMHERAEUS KULZER LLCEEF13A50057352R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-080

Event Narratives#

D

Patient 1

DEALER REP. HAS A CLAMP THAT WAS RETURNED FOR CREDIT BECAUSE IT BROKE AFTER A WEEK IN USE. CALLED OFFICE AND LEFT MESSAGE TO FOLLOW-UP.

N

Patient 1

ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "DO NOT PLACE CLAMP IN MOUTH UNTIL THE RUBBER DAM HAS BEEN PROPERLY PLACED. CLAMP COULD BECOME A CHOKING OR SAFETY HAZARD IF DROPPED OR BROKEN IN THE MOUTH WITHOUT PROPER USE OF THE RUBBER DAM AT ALL TIMES."