INPLANT FUNNEL IN-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-20 for INPLANT FUNNEL IN-001 manufactured by Proximate Concepts, Llc.

MAUDE Entry Details

Report NumberMW5087519
MDR Report Key8722902
Date Received2019-06-20
Date of Report2019-06-18
Date of Event2019-04-11
Date Added to Maude2019-06-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINPLANT FUNNEL
Generic NameKIT SURGICAL INSTRUMENT DISPOSABLE
Product CodeKDD
Date Received2019-06-20
Model NumberIN-001
Lot Number111218
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPROXIMATE CONCEPTS, LLC
Manufacturer AddressFORT LEE NJ 07024 US 07024


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-20

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