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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. DEPRESSOR, TONGUE, NON-SURGICAL

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MEDLINE INDUSTRIES, INC. DEPRESSOR, TONGUE, NON-SURGICAL Back to Search Results
Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2016
Event Type  malfunction  
Event Description
During extubation, anesthesiologist noted tongue blade was broken and portion missing.
 
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Type of DeviceDEPRESSOR, TONGUE, NON-SURGICAL
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
one medline pl.
mundelein IL 60060
MDR Report Key6120906
MDR Text Key60679623
Report Number6120906
Device Sequence Number1
Product Code FMA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer09/29/2016
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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