CARBON STEEL SCALPEL BLADES #10 BB510

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 2020-01-29 for CARBON STEEL SCALPEL BLADES #10 BB510 manufactured by Aesculap Ag.

Event Text Entries

[179494329] 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


[179494330] It was reported that there was an issue with carbon steel scalpel blade. Following information was reported: a new box of blades had been ordered and was spot-tested. Pin holes were not detected at the distribution center. However, the customer reported that the holes appear usually in 1 of every 20-30 blades opened. The product was not used on a patient. The adverse event/malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00933
MDR Report Key9643122
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-29
Date of Report2020-02-26
Date of Event2019-12-19
Date Mfgr Received2020-02-07
Device Manufacturer Date2019-07-24
Date Added to Maude2020-01-29
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 ContactMS KERSTIN ROTHWEILER
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal78501
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 #10
Generic NameGENERAL SURGICAL INSTRUMENTS
Product CodeGES
Date Received2020-01-29
Returned To Mfg2020-01-22
Model NumberBB510
Catalog NumberBB510
Lot Number4510886571
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
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 2020-01-29

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