TC METZENBAUM SCISSORS DEL CVD 200MM BC275R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-03-29 for TC METZENBAUM SCISSORS DEL CVD 200MM BC275R manufactured by Aesculap Ag.

Event Text Entries

[140312188] (b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[140312189] It was reported by the healthcare professional "that the wrong item number is on the scissors. " the product is mislabeled. All medwatch submissions related to this are: 9610612-2019-00203, 9610612-2019-00205.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00204
MDR Report Key8464016
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-03-29
Date of Report2019-03-28
Date Facility Aware2019-03-21
Date Mfgr Received2019-03-11
Device Manufacturer Date2017-01-13
Date Added to Maude2019-03-29
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 Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
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 NameTC METZENBAUM SCISSORS DEL CVD 200MM
Generic NameDUROTIP SCISSORS
Product CodeLRW
Date Received2019-03-29
Returned To Mfg2019-03-12
Model NumberBC275R
Catalog NumberBC275R
Lot Number4508252684
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2019-03-29

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