HEAL COLLAR 3.5X4.5, 5MM HC345

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-11-22 for HEAL COLLAR 3.5X4.5, 5MM HC345 manufactured by Zimmer Dental.

MAUDE Entry Details

Report Number0002023141-2019-01146
MDR Report Key9362538
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2019-11-22
Date of Report2019-11-22
Date Mfgr Received2019-10-23
Device Manufacturer Date2018-11-20
Date Added to Maude2019-11-22
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 ContactMS SUSANNE TAYLOR
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal33410
Manufacturer Phone5617766700
Manufacturer G1ZIMMER DENTAL
Manufacturer Street4555 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal Code33410
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEAL COLLAR 3.5X4.5, 5MM
Generic NameHEALING COLLAR
Product CodeNHA
Date Received2019-11-22
Returned To Mfg2019-10-23
Catalog NumberHC345
Lot Number2018111245
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerZIMMER DENTAL
Manufacturer Address4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-22

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