DRACO HY0305Z

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for DRACO HY0305Z manufactured by Cygnus Medical, Llc.

Event Text Entries

[143241498] Deep cleaning pads were found with mold inside sealed package. Expiration date: 12/31/2020. Box was thrown away so we are unsure of the lot number.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8554494
MDR Report Key8554494
Date Received2019-04-26
Date of Report2019-04-17
Date of Event2019-04-16
Report Date2019-04-17
Date Reported to FDA2019-04-17
Date Reported to Mfgr2019-04-26
Date Added to Maude2019-04-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDRACO
Generic NameACCESSORIES, CLEANING, PAD
Product CodeFRL
Date Received2019-04-26
Model NumberHY0305Z
Catalog NumberHY0305Z
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCYGNUS MEDICAL, LLC
Manufacturer Address965 W MAIN ST BRANFORD CT 06405 US 06405


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-26

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