HYGENIC H09946

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for HYGENIC H09946 manufactured by Coltene Whaledent Inc..

Event Text Entries

[118242036] Dental dam tore in a zipper like motion. Tear was noticed during procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2416455-2018-08233
MDR Report Key7808495
Date Received2018-08-23
Date of Report2018-09-28
Date of Event2018-04-25
Date Mfgr Received2018-04-25
Date Added to Maude2018-08-23
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
Product CodeEIE
Date Received2018-08-23
Catalog NumberH09946
Lot Number017J
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOLTENE WHALEDENT INC.
Manufacturer Address235 ASCOT PARKWAY CUYAHOGA FALLS OH 44223 US 44223


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-23

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