IVORY CLAMP 50057304

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-17 for IVORY CLAMP 50057304 manufactured by Heraeus Kulzer, Llc.

Event Text Entries

[48779435] 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. This malfunction is reportable as sec. 803. 50 states: if you are a manufacturer, you must report to us no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. The malfunction will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution. Distorting the clamp during usage causing breakage of the clamp. 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. " the directions for use warns, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " the user used the clamp in a manner that is contraindicated. The clamp had been severely torqued and severely hyperextended, leading to metal fatigue.
Patient Sequence No: 1, Text Type: N, H10


[48779436] This complaint is from (b)(6). Dealer returned clamp with note: broken clamp.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1821514-2016-00016
MDR Report Key5732079
Date Received2016-06-17
Date of Report2016-05-26
Date Mfgr Received2016-05-31
Device Manufacturer Date2014-07-31
Date Added to Maude2016-06-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. RITA ROGERS
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5742995409
Manufacturer G1HERAEUS KULZER, LLC
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 466142517
Manufacturer CountryUS
Manufacturer Postal Code466142517
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIVORY CLAMP
Generic NameCLAMP, RUBBER DAM
Product CodeEEF
Date Received2016-06-17
Returned To Mfg2016-05-31
Catalog Number50057304
Lot NumberC4
Device Expiration Date2019-07-31
OperatorDENTIST
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER, LLC
Manufacturer Address300 HERAEUS WAY SOUTH BEND IN 466142517 US 466142517


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-17

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