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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. STERILE TONGUE DEPRESSOR, 6" DEPRESSOR, TONGUE, NON-SURGICAL

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MEDLINE INDUSTRIES, INC. STERILE TONGUE DEPRESSOR, 6" DEPRESSOR, TONGUE, NON-SURGICAL Back to Search Results
Catalog Number MDS202075
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 01/31/2020
Event Type  Injury  
Event Description
Patient was undergoing a gyn surgical procedure. The intubation was difficult. The certified registered nurse anesthetist (crna) used a tongue depressor to expose the base of the tongue and the distal tip of the tongue depressor broke off and was lost in the patient's aerodigestive tract. An ent was consulted for removal while the patient was in the operation room. The foreign body was removed from the right nasopharynx. The patient was admitted for observation following the removal. The patient underwent further studies and the patient was diagnosed with a hypopharyngeal/pharyngeal perforation, confirmed free air in the neck, significant dysphagia and odynophagia, and contrast aspiration.
 
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Brand NameSTERILE TONGUE DEPRESSOR, 6"
Type of DeviceDEPRESSOR, TONGUE, NON-SURGICAL
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key9670475
MDR Text Key177795716
Report Number9670475
Device Sequence Number1
Product Code FMA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMDS202075
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2020
Event Location Hospital
Date Report to Manufacturer02/05/2020
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

Patient Treatment Data
Date Received: 02/05/2020 Patient Sequence Number: 1
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