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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LMA LARYNGEAL MASK AIRWAY; NONE
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LMA LARYNGEAL MASK AIRWAY; NONE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Inflammation (1932); Sore Throat (2396); No Code Available (3191)
Event Date 07/18/2014
Event Type  Injury  
Event Description
I went in for a same-day surgery on a friday to remove a mass on my left thigh.When i came out of the anesthesia i was unable to speak or swallow liquids.I was told it was hoarseness and would just go away within a couple of hours/days.Three days later i still was unable to speak or swallow liquids without choking.I made an appointment with an ent on monday to be seen on wednesday.On tuesday i saw the surgeon who said it would clear up.Wednesday i saw an ent who originally diagnosed me with arytenoid dislocation and could become permanent.I was sent for an emergency consult on thursday to a laryngologist.Wednesday night the anesthesiologist called to see how i was doing and she said i was not intubated.They had use a lma during surgery and not a tube.Thursday when i went to see the laryngologist he stated i had an inflamed/injured muscles near the vocal cord from the lma.In addition, i had black and blue marks in my throat.I was put on a high-dose of prednisone for 10 days and will have to return in 2 weeks for a follow-up.So far the prednisone has started to help me heal and hopefully this will continue.
 
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Brand Name
LMA LARYNGEAL MASK AIRWAY
Type of Device
NONE
MDR Report Key3972756
MDR Text Key4755346
Report NumberMW5037512
Device Sequence Number1
Product Code CAE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/28/2014
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age68 YR
Patient Weight61
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