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 other report with the FDA on 2018-11-29 for ROUND FILTERS W/INDICATOR US751 manufactured by Aesculap Inc.

Event Text Entries

[128925416] (b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[128925417] It was reported to the company sales representative "customer noticed additional indicator ink spots on filter. " it was reported that there was no patient injury and no delay in surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2018-00040
MDR Report Key8117227
Report SourceOTHER
Date Received2018-11-29
Date of Report2018-11-28
Date of Event2018-09-30
Date Facility Aware2018-09-29
Date Mfgr Received2018-08-30
Date Added to Maude2018-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 G1SPS MEDICAL SUPPLY CORP
Manufacturer Street6789 W HENRIETTA ROAD
Manufacturer CityRUSH NY 14543
Manufacturer CountryUS
Manufacturer Postal Code14543
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROUND FILTERS W/INDICATOR
Generic NameDISPOSABLES CONTAINER SYSTEM
Product CodeKCT
Date Received2018-11-29
Model NumberUS751
Catalog NumberUS751
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2018-11-29

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