CARTIVA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-08 for CARTIVA manufactured by Cartiva, Inc..

MAUDE Entry Details

Report NumberMW5087964
MDR Report Key8772788
Date Received2019-07-08
Date of Report2019-07-08
Date of Event2016-02-02
Date Added to Maude2019-07-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameCARTIVA
Generic NamePROSTHESIS, TOE, HEMI-, PHALANGEAL
Product CodeKWD
Date Received2019-07-08
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerCARTIVA, INC.

Device Sequence Number: 1

Brand NameCARTIVA
Generic NamePROSTHESIS, TOE, HEMI-, PHALANGEAL
Product CodeKDW
Date Received2019-07-08
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARTIVA, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-07-08

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