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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH, INC. / AVANOS MEDICAL INC. HALYARD ONE STEP QUICK CHECK WRAP STERILIZATION WRAP

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HALYARD HEALTH, INC. / AVANOS MEDICAL INC. HALYARD ONE STEP QUICK CHECK WRAP STERILIZATION WRAP Back to Search Results
Device Problem Material Puncture/Hole (1504)
Patient Problem No Information (3190)
Event Date 07/30/2018
Event Type  malfunction  
Event Description
Halyard one step quick check wrap and halyard wrap smart-fold - used to wrap surgical instrument trays for sterilization; found to have slits and holes in the material of over 30 wrappers over the course of several months ((b)(6) 2018 - (b)(6) 2018).
 
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Brand NameHALYARD ONE STEP QUICK CHECK WRAP
Type of DeviceSTERILIZATION WRAP
Manufacturer (Section D)
HALYARD HEALTH, INC. / AVANOS MEDICAL INC.
alpharetta GA 30004
MDR Report Key7742696
MDR Text Key116047185
Report NumberMW5078786
Device Sequence Number0
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/01/2018 Patient Sequence Number: 1
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