ROUND FILTERS W/INDICATOR US751

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-23 for ROUND FILTERS W/INDICATOR US751 manufactured by Aesculap Inc.

MAUDE Entry Details

Report Number2916714-2019-00057
MDR Report Key9105470
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-09-23
Date of Report2019-09-23
Date of Event2019-08-28
Date Mfgr Received2019-08-28
Date Added to Maude2019-09-23
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. LINDSAY CHROMIAK
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY PA 18034
Manufacturer CountryUS
Manufacturer Postal18034
Manufacturer G1AESCULAP INC
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY PA 18034
Manufacturer CountryUS
Manufacturer Postal Code18034
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROUND FILTERS W/INDICATOR
Generic NameSTERILE TECHNOLOGY
Product CodeKCT
Date Received2019-09-23
Model NumberUS751
Catalog NumberUS751
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP INC
Manufacturer Address3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-23

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