MOZEC? NC - RX PTCA BALLOON DILATATION CATHETER MNC25035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-30 for MOZEC? NC - RX PTCA BALLOON DILATATION CATHETER MNC25035 manufactured by Meril Life Sciences Private Limited.

MAUDE Entry Details

Report Number3009613036-2019-00004
MDR Report Key9392241
Report SourceDISTRIBUTOR
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-11-01
Date Mfgr Received2019-11-08
Device Manufacturer Date2017-07-01
Date Added to Maude2019-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. NARENDRA PATEL
Manufacturer StreetSURVEY NUMBER 135/139 BILAKHIA HOUSE, MUKTANAND MARG
Manufacturer CityCHALA, VAPI, GUJARAT 396191
Manufacturer CountryIN
Manufacturer Postal396191
Manufacturer G1MERIL LIFE SCIENCES PRIVATE LIMITED
Manufacturer StreetSURVEY NUMBER 135/139 BILAKHIA HOUSE, MUKTANAND MARG
Manufacturer CityCHALA, VAPI, 396191
Manufacturer CountryIN
Manufacturer Postal Code396191
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMOZEC? NC - RX PTCA BALLOON DILATATION CATHETER
Generic NameRAPID EXCHANGE PTCA BALLOON DILATATION CATHETER
Product CodeLOX
Date Received2019-11-30
Model NumberMNC25035
Catalog NumberMNC25035
Lot NumberMNCG99
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMERIL LIFE SCIENCES PRIVATE LIMITED
Manufacturer AddressSURVEY NUMBER 135/139 BILAKHIA HOUSE, MUKTANAND MARG CHALA, VAPI, 396191 IN 396191


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-30

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