SPROTTE 511151-29A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for SPROTTE 511151-29A manufactured by Pajunk Gmbh Medizintechnologie.

MAUDE Entry Details

Report Number9611612-2019-00024
MDR Report Key9143774
Date Received2019-10-02
Date of Report2019-10-02
Date of Event2019-09-05
Date Mfgr Received2019-09-05
Device Manufacturer Date2017-07-04
Date Added to Maude2019-10-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR CHRISTIAN QUASS
Manufacturer StreetKARL-HALL-STR. 1 TUTTLINGER STR. 7
Manufacturer CityGEISINGEN, 78187
Manufacturer CountryGM
Manufacturer Postal78187
Manufacturer G1PAJUNK GMBH MEDIZINTECHNOLOGIE
Manufacturer StreetKARL-HALL-STR. 1 TUTTLINGER STR. 7
Manufacturer CityGEISINGEN, 78187
Manufacturer CountryGM
Manufacturer Postal Code78187
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSPROTTE
Generic NameNEEDLE, ANAESTHESIA CONDUCTION, SINGLE SHOT
Product CodeBSP
Date Received2019-10-02
Model Number511151-29A
Catalog Number511151-29A
Lot Number1299
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPAJUNK GMBH MEDIZINTECHNOLOGIE
Manufacturer AddressKARL-HALL-STR. 1 TUTTLINGER STR. 7 GEISINGEN, 78187 GM 78187


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-02

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