FLEXITIME CORRECT FLOW 50034806

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-11 for FLEXITIME CORRECT FLOW 50034806 manufactured by Kulzer Srl.

Event Text Entries

[113695508] (b)(4). Additional information surrounding event: reporting staff member stated that she was not in the room with the patient when the reaction occured, but that she is aware of the details due to the patient being the sister of one of the hygienist's at the office. Details are as follows: after impressions were taken with flexitime easy putty and flexitime correct flow the patient felt as if her throat was closing and she was having a hard time breathing. Patient remained at the dental office for an hour and then left, taking her children to lunch. Patient did not seek medical attention. Patient's sister who is an office employee followed up with her the next day and the patient's symptoms had resolved. Lot number of material is not available as the material used for the patient was completely used and the cartridge was disposed of. Office reviewed the sds online and is stating that one of the ingredients listed, has a potential to affect patients who have a shell fish allergy (global safety manager was consulted on this claim via informal). Flexitime easy putty is being submitted to fda as well using reporting number: 3011203516-2018-00001.
Patient Sequence No: 1, Text Type: N, H10


[113695509] Impressions were being taken on patient for invisalign. Patient felt like her throat was closing. Follow up with office: after impressions were taken with ft ep and cf the patient felt as if her throat was closing and she was having a hard time breathing. Patient remained at the dental office for an hour and then left. Patient did not seek medical attention. Patient's sister who is an office employee followed up with her the next day and the patient's symptoms had resolved. Lot number of material is not available as the material used for the patient was completely used and the cartridge was disposed of. Office reviewed the sds online and is stating that one of the ingredients listed, has a potential to affect patients who have a shell fish allergy (global safety manager was consulted and responded, "i screened the ingredients list of the products. I have no clue, which of the ingredients might initiate a cross-allergic reaction with seafood or shellfish and i never heard of such a crossreaction. If they are asking if we are aware of such a reaction, i can clearly state no! ".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011203516-2018-00002
MDR Report Key7678820
Report SourceHEALTH PROFESSIONAL
Date Received2018-07-11
Date of Report2018-07-09
Date of Event2018-06-15
Date Facility Aware2018-06-15
Date Mfgr Received2018-06-15
Date Added to Maude2018-07-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS AMBER BROWN
Manufacturer Street4315 S. LAFAYETTE BLVD
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5472995411
Manufacturer G1KULZER, LLC
Manufacturer Street4315 S. LAFAYETTE BLVD
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal Code46614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXITIME CORRECT FLOW
Generic NameIMPRESSION MATERIAL
Product CodeELW
Date Received2018-07-11
Catalog Number50034806
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKULZER SRL
Manufacturer AddressDIETCH HONOLD 1 CLADERIA C3 SACALAZ-JUDETUL, TIMIS 307370 RO 307370


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-07-11

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