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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIANJIN MEDIS MEDICAL DEVICE CO. ULTRA CLEAR LARYNGEAL MASK; LARYNGEAL MASK AIRWAY

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TIANJIN MEDIS MEDICAL DEVICE CO. ULTRA CLEAR LARYNGEAL MASK; LARYNGEAL MASK AIRWAY Back to Search Results
Model Number 1036050
Device Problem Misassembled (1398)
Patient Problem No Information (3190)
Event Date 12/23/2013
Event Type  Injury  
Event Description
Laryngeal mask cuff separated from laryngeal mask tube while being removed from patient.
 
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Brand Name
ULTRA CLEAR LARYNGEAL MASK
Type of Device
LARYNGEAL MASK AIRWAY
Manufacturer (Section D)
TIANJIN MEDIS MEDICAL DEVICE CO.
tianjin
CH 
Manufacturer (Section G)
ANESTHESIA EQUIPMENT SUPPLY, INC.
24301 roberts dr.
black diamond WA 98010
Manufacturer Contact
24301 roberts dr.
black diamond, WA 98010
MDR Report Key3670417
MDR Text Key19804224
Report Number3022477-2014-00001
Device Sequence Number1
Product Code CAE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/19/2016
Device Model Number1036050
Device Catalogue Number1036050
Device Lot Number0520000002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2014
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/07/2014
Device Age8 MO
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer02/27/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/28/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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