HYGENIC H02705

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for HYGENIC H02705 manufactured by Coltene Whaledent Inc..

Event Text Entries

[117852002] Clamp broke after two uses. Clamp was drenched in multisept plus. Clean clamp was sterilized by autoclaving at 134 degrees.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2416455-2018-00006
MDR Report Key7796687
Date Received2018-08-20
Date of Report2018-08-29
Date of Event2018-06-19
Date Added to Maude2018-08-20
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 ContactTRICIA CREGGER
Manufacturer Street235 ASCOT PARKWAY
Manufacturer CityCUYAHOGA FALLS OH 44223
Manufacturer CountryUS
Manufacturer Postal44223
Manufacturer G1COLTENE WHALEDENT INC.
Manufacturer Street235 ASCOT PARKWAY
Manufacturer CityCUYAHOGA FALLS OH 44223
Manufacturer CountryUS
Manufacturer Postal Code44223
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHYGENIC
Generic NameDENTAL DAM CLAMP
Product CodeEEF
Date Received2018-08-20
Catalog NumberH02705
Lot NumberH77566
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOLTENE WHALEDENT INC.
Manufacturer Address235 ASCOT PARKWAY CUYAHOGA FALLS OH 44223 US 44223


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.