NOVO HEALTH SERVICES 514000 7404

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-01-30 for NOVO HEALTH SERVICES 514000 7404 manufactured by Novo Health Services.

Event Text Entries

[134491486] On (b)(6) 2019, the end user, surgical technician/nurse, was completing their set-up for a total knee replacement procedure, when they noticed a small hole/slit in their right sleeve of a surgical gown (7403). The operating room was broken down and then reset-up for the case, while the patient was under anesthesia. This led to the patient having extending time under anesthesia, potential adverse reaction. The small hole/slit in the gown sleeve was verified by the quality manager (qm). The qm provided training with the inspection staff, informing them on possible outcomes. Procedures and policies were reviewed and no changes are noted at this time. It was reported that there was no adverse impact to the patient as a result of extended time under anesthesia and no further information has been provided.
Patient Sequence No: 1, Text Type: N, H10


[134491487] On (b)(6) 2019, the end user was setting up the operating room for a total knee replacement procedure. The surgical technician noticed a hole in the right sleeve, after sterile set-up was completed and the patient was under anesthesia.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000306225-2018-00016
MDR Report Key8289113
Report SourceDISTRIBUTOR
Date Received2019-01-30
Date of Report2019-01-16
Date of Event2019-01-09
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2019-01-10
Date Added to Maude2019-01-30
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 ContactZILLERY FORNTER
Manufacturer Street7086 INDUSTRIAL ROW DRIVE
Manufacturer CityMASON OH 45040
Manufacturer CountryUS
Manufacturer Postal45040
Manufacturer Phone5133986406
Manufacturer G1NOVO HEALTH SERVICES
Manufacturer Street4501 E. ACLINE DRIVE SUITE 1
Manufacturer CityTAMPA FL 33605
Manufacturer CountryUS
Manufacturer Postal Code33605
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOVO HEALTH SERVICES
Generic NameGOWN, SURGICAL, L3
Product CodeFYA
Date Received2019-01-30
Returned To Mfg2019-01-10
Model Number514000
Catalog Number7404
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNOVO HEALTH SERVICES
Manufacturer Address4501 E. ACLINE DRIVE TAMPA FL 33605 US 33605


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-01-30

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