CARBON STEEL SAFETY SCALPEL #21 BA821SU

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 2019-04-23 for CARBON STEEL SAFETY SCALPEL #21 BA821SU manufactured by Aesculap Ag.

Event Text Entries

[142815105] (b)(4). Manufacturing site evaluation: investigation on-going. Additional information/investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[142815106] It was reported that there was an issue with a scalpel. During an unspecified procedure, the scalpel did not engage. The incision was then longer than planned. Additional information was not provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00283
MDR Report Key8541702
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-04-23
Date of Report2019-04-23
Date Facility Aware2019-04-17
Date Mfgr Received2019-04-05
Device Manufacturer Date2018-12-13
Date Added to Maude2019-04-23
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 ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
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 SAFETY SCALPEL #21
Generic NameBASIC INSTRUMENTS
Product CodeGDX
Date Received2019-04-23
Returned To Mfg2019-04-15
Model NumberBA821SU
Catalog NumberBA821SU
Lot Number4510270165
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-04-23

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