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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS ANESTHESIA CONDUCTION KIT

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AVANOS MEDICAL, INC. AVANOS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 99794
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2020
Event Type  malfunction  
Event Description
Sterility issue: after opening avanos universal block tray ref#(b)(4) lot#20023460 exp. 2022-06-01; a black hair was discovered in pack. Pack removed and new set up began prior to patient entering operating room.
 
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Brand NameAVANOS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key10464862
MDR Text Key204735227
Report Number10464862
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number99794
Device Catalogue Number181A432
Device Lot Number20023460
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/10/2020
Event Location Hospital
Date Report to Manufacturer08/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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