AVID CUSTOM PROCEDURE TRAYS N021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-16 for AVID CUSTOM PROCEDURE TRAYS N021 manufactured by Owens & Minor, Tec..

Event Text Entries

[75751810] Operating room staff reported finding hair located within the plastic bag of the custom pack. Pack could not be used. Manufacture date: 12/29/2016.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069879
MDR Report Key6578035
Date Received2017-05-16
Date of Report2017-05-16
Date of Event2017-03-31
Date Added to Maude2017-05-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAVID CUSTOM PROCEDURE TRAYS
Generic NameCYSTO PACK / TRAY, SURGICAL
Product CodeLRP
Date Received2017-05-16
Catalog NumberN021
Lot Number1203396
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerOWENS & MINOR, TEC.
Manufacturer Address9120 LOCKWOOD BLVD. MECHANICSVILLE VA 23116 US 23116


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-16

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