CARBON STEEL SCALPEL #11 BA211

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 2019-02-20 for CARBON STEEL SCALPEL #11 BA211 manufactured by Aesculap Ag.

Event Text Entries

[136769036] (b)(4). Manufacturing site evaluation: ongoing. If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[136769037] It was reported that the blade was rusty after use on patient intraoperatively. It was reported that the #11 blade is showing signs of oxidation after use on the patient and when in contact with 0. 9% saline. No patient harm reported. Additional information has been requested, however, not yet received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00111
MDR Report Key8356122
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-02-20
Date of Report2019-02-28
Date of Event2019-01-19
Date Facility Aware2019-02-12
Date Mfgr Received2019-02-26
Device Manufacturer Date2018-04-18
Date Added to Maude2019-02-20
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 ContactMRS. NICOLE BROYLES
Manufacturer Street1 A RAUMANTIE
Manufacturer CityHELSINKI MO 00350
Manufacturer CountryFI
Manufacturer Postal00350
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 SCALPEL #11
Generic NameDISPOSABLE SCALPELS
Product CodeGDX
Date Received2019-02-20
Model NumberBA211
Catalog NumberBA211
Lot Number4509374494
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age9 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-20

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