CARBON STEEL SCALPEL BLADES #15 BB515

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 2019-06-05 for CARBON STEEL SCALPEL BLADES #15 BB515 manufactured by Aesculap Ag.

MAUDE Entry Details

Report Number9610612-2019-00360
MDR Report Key8671889
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-06-05
Date of Report2019-06-05
Date Facility Aware2019-05-27
Date Mfgr Received2019-05-08
Device Manufacturer Date2018-06-08
Date Added to Maude2019-06-05
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 ContactMS. LINDSAY CHROMIAK
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY PA 18034
Manufacturer CountryUS
Manufacturer Postal18034
Manufacturer Phone8002581946
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARBON STEEL SCALPEL BLADES #15
Generic NameSCALPEL BLADES
Product CodeGES
Date Received2019-06-05
Returned To Mfg2019-05-14
Model NumberBB515
Catalog NumberBB515
Lot Number4509746734
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-05

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