MALIBU/SOVEREIGN (INCL. DIGNITY) AZL23110-GB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-16 for MALIBU/SOVEREIGN (INCL. DIGNITY) AZL23110-GB manufactured by Arjohuntleigh Polska Sp. Z O.o..

MAUDE Entry Details

Report Number3007420694-2020-00006
MDR Report Key9595668
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-16
Date of Report2020-02-12
Date of Event2020-01-02
Date Mfgr Received2020-01-02
Device Manufacturer Date2015-06-08
Date Added to Maude2020-01-16
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 ContactKINGA STOLINSKA
Manufacturer StreetKS. WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI 62-052
Manufacturer CountryPL
Manufacturer Postal62-052
Manufacturer Phone688282467
Manufacturer G1ARJOHUNTLEIGH MAGOG INC.
Manufacturer Street2001 TANGUAY STREET
Manufacturer CityMAGOG J1X5Y5
Manufacturer CountryCA
Manufacturer Postal CodeJ1X5Y5
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMALIBU/SOVEREIGN (INCL. DIGNITY)
Generic NameBATH, HYDRO-MASSAGE
Product CodeILJ
Date Received2020-01-16
Model NumberAZL23110-GB
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARJOHUNTLEIGH POLSKA SP. Z O.O.
Manufacturer AddressUL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI PL-62052 PL PL-62052


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-16

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