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,health report with the FDA on 2020-02-05 for ROUND FILTERS W/ INDICATOR US751 manufactured by Aesculap, Inc..

Event Text Entries

[178330262] Manufacturing evaluation: investigation on-going. Upon completion, should additional relevant information become available, a supplemental medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[178330263] It was reported that the sterile set round filter was found to be "slashed/punctured. " the exact event date was unknown. Although the incident did occur in surgery, it did not cause or contribute to serious injury or death. This incident did cause a delay in surgery of an unknown amount of time. No intervention was required as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2020-00023
MDR Report Key9671411
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-05
Date of Report2020-02-05
Date Mfgr Received2020-01-07
Date Added to Maude2020-02-05
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 Phone6109849072
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 NameDISPOSABLES
Product CodeKCT
Date Received2020-02-05
Model NumberUS751
Catalog NumberUS751
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP, INC.
Manufacturer Address3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-05

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