RCT RESORBABLE COLLAGEN TAPE 5091000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-28 for RCT RESORBABLE COLLAGEN TAPE 5091000 manufactured by Collagen Matrix, Inc..

MAUDE Entry Details

Report Number2249852-2020-00003
MDR Report Key9771255
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-02-28
Date of Report2020-03-13
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-02-28
Date Added to Maude2020-02-28
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 ContactGLORIA ZUCLICH
Manufacturer Street15 THORNTON ROAD
Manufacturer CityOAKLAND, NJ
Manufacturer CountryUS
Manufacturer Phone4051477317
Manufacturer G1COLLAGEN MATRIX, INC.
Manufacturer Street15 THORNTON ROAD
Manufacturer CityOAKLAND, NJ
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRCT RESORBABLE COLLAGEN TAPE
Generic NameCOLLAGEN WOUND DRESSING - ORAL
Product CodeKGN
Date Received2020-02-28
Model Number5091000
Catalog Number5091000
Lot NumberDWTN18P3
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOLLAGEN MATRIX, INC.
Manufacturer Address15 THORNTON ROAD OAKLAND, NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-28

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