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Adverse Event Report

U.S. DENTEK CORP. TEMPARIN TEMPORARY TOOTH FILLING MIX   back to search results
Lot Number GF10/10 1304A
Patient Outcome  Life Threatening; Required Intervention
Event Description

Products states it is the same ingredients used by dentist. Temparin hardens in the mouth with salvia after a while, unlike being immediately hardened by ultra violet light by the dentist. As stated by the instructions, rptr cleaned the area, placed the pre-mixed mix into the cavity, bite down to secure it and allowed it to harden. Rptr experienced a bit of nausea but didn't associate it with the product at the time. Rptr used the product again a few weeks later. Rptr placed the temparin in just before rptr went to bed so that there would be no interference with it hardening. Rptr was awaken from sleep by a terrible feeling of nausea. Rptr awoke sweaty, rptr's heart was beating very, very fast. Rptr had the taste of the mixture in their mouth, as well as the white residue rptr thought rptr was having a heart attack but there was no pain. Rptr laid still frightened that if rptr moved rptr would trigger some pain. Eventually, the reaction faded away. Rptr thought maybe the reactions was brought on by a lack of eating. Rptr used the product again, when rptr knew rptr had eaten properly. Rptr experienced the same reaction nausea sweating, irratic heartbeat. The symptoms seem similar to those the medical profession attribute to heart attack rptr has read the directions carefully, no listing of side effects, nor abstainance, etc is noted. Since using this product rptr has heart palpitations daily. On actual package purchased, package states harden with salvia. On new package of temparin, all instructions printed with exception to the omission of hardens with salvia.

 
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Brand NameTEMPARIN
Type of DeviceTEMPORARY TOOTH FILLING MIX
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
U.S. DENTEK CORP.
4160 cader ln
petaluma CA 94954
Device Event Key357594
MDR Report Key368479
Event Key347499
Report NumberMW1023667
Device Sequence Number1
Product CodeEMB
Report Source Voluntary
Report Date 11/17/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device LOT NumberGF10/10 1304A
Was Device Available For Evaluation? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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