JACKSON-PRATT CHANNEL DRAIN JP-2189 11003811580CR

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 2019-11-26 for JACKSON-PRATT CHANNEL DRAIN JP-2189 11003811580CR manufactured by Degania Silicone Ltd.

MAUDE Entry Details

Report Number8030107-2019-00022
MDR Report Key9375035
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2019-11-26
Date of Report2019-11-26
Date of Event2019-07-19
Date Mfgr Received2019-11-26
Date Added to Maude2019-11-26
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 ContactMRS. KATIA KAYAM
Manufacturer StreetDEGANIA BET
Manufacturer CityDEGANIA BET, JORDAN VALLEY 1513000
Manufacturer CountryIS
Manufacturer Postal1513000
Manufacturer G1DEGANIA SILICONE LTD
Manufacturer StreetDEGANIA BET
Manufacturer CityDEGANIA BET, 1513000
Manufacturer CountryIS
Manufacturer Postal Code1513000
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number8030107-06/28/2019-001-R
Event Type3
Type of Report3

Device Details

Brand NameJACKSON-PRATT CHANNEL DRAIN
Generic NameSILICONE FLUTED 15FR DRAIN
Product CodeGCB
Date Received2019-11-26
Model NumberJP-2189
Catalog Number11003811580CR
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEGANIA SILICONE LTD
Manufacturer AddressDEGANIA BET DEGANIA BET, 1513000 IS 1513000


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-26

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