TEMPARIN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-20 for TEMPARIN * manufactured by U.s. Dentek Corp..

Event Text Entries

[240691] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1023667
MDR Report Key368479
Date Received2001-12-20
Date of Report2001-11-17
Date of Event2001-07-01
Date Added to Maude2001-12-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTEMPARIN
Generic NameTEMPORARY TOOTH FILLING MIX
Product CodeEMB
Date Received2001-12-20
Model Number*
Catalog Number*
Lot NumberGF10/10 1304A
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key357594
ManufacturerU.S. DENTEK CORP.
Manufacturer Address4160 CADER LN PETALUMA CA 94954 US


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2001-12-20

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