DORO? QR3 SKULL CLAMP 1001.001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2020-03-24 for DORO? QR3 SKULL CLAMP 1001.001 manufactured by Pro Med Instruments Gmbh.

MAUDE Entry Details

Report Number3003923584-2020-00004
MDR Report Key9870899
Report SourceDISTRIBUTOR,USER FACILITY
Date Received2020-03-24
Date of Report2020-02-25
Date of Event2020-02-24
Date Mfgr Received2020-02-25
Device Manufacturer Date2015-03-30
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. ERASMUS BAUMANN
Manufacturer StreetBOETZINGER STR. 38
Manufacturer CityFREIBURG, 79111
Manufacturer CountryGM
Manufacturer Postal79111
Manufacturer G1PRO MED INSTRUMENTS GMBH
Manufacturer StreetBOETZINGER STR. 38
Manufacturer CityFREIBURG, 79111
Manufacturer CountryGM
Manufacturer Postal Code79111
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDORO? QR3 SKULL CLAMP
Generic NameDORO? QR3 SKULL CLAMP
Product CodeHBL
Date Received2020-03-24
Returned To Mfg2020-03-02
Model Number1001.001
Catalog Number1001.001
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPRO MED INSTRUMENTS GMBH
Manufacturer AddressBOETZINGER STR. 38 FREIBURG, 79111 GM 79111


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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