TRACHEOSTOMY CLEAN AND CARE TRAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-17 for TRACHEOSTOMY CLEAN AND CARE TRAY manufactured by Medline Industries, Inc..

Event Text Entries

[21262125] Pt being cared for at a home. When tracheostomy care kit was opened by family member, black matter was noted on a gauze dressing in the kit. The home care nurse subsequently opened another kit from the same lot number, and it also contained a gauze with black matter on it. Neither dressing was used on the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5026585
MDR Report Key2711103
Date Received2012-08-17
Date of Report2012-08-17
Date of Event2012-08-09
Date Added to Maude2012-08-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTRACHEOSTOMY CLEAN AND CARE TRAY
Generic NameNONE
Product CodeOGV
Date Received2012-08-17
Lot Number12CY0032
ID NumberREF# DYND40610
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressONE MEDLINE PL. MUNDELEIN IL 60060 US 60060


Patients

Patient NumberTreatmentOutcomeDate
10 2012-08-17

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