SCRRACK F/VC NO. 683.017 W/O CONT 683.018

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-23 for SCRRACK F/VC NO. 683.017 W/O CONT 683.018 manufactured by Oberdorf Synthes Produktions Gmbh.

MAUDE Entry Details

Report Number8030965-2020-00584
MDR Report Key9623489
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-23
Date of Report2020-01-03
Date Mfgr Received2020-03-11
Date Added to Maude2020-01-23
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 ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer G1WERK H
Manufacturer StreetIM BIFANG 6
Manufacturer CityHAEGENDORF 4614
Manufacturer CountrySZ
Manufacturer Postal Code4614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCRRACK F/VC NO. 683.017 W/O CONT
Generic NameTRAY, SURGICAL INSTRUMENT
Product CodeFSM
Date Received2020-01-23
Catalog Number683.018
Lot Number1040306
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-23

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