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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIANJIN KINDWELL MEDICAL EQUIPMENT CO. LTD ULTRA CLEAR LARYNGEAL MASK; LARYNGEAL MASK AIRWAY
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TIANJIN KINDWELL MEDICAL EQUIPMENT CO. LTD ULTRA CLEAR LARYNGEAL MASK; LARYNGEAL MASK AIRWAY Back to Search Results
Model Number 1036050
Device Problem Misassembled (1398)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2014
Event Type  malfunction  
Event Description
Laryngeal mask cuff separated from laryngeal mask tube while being removed from patient.
 
Manufacturer Narrative
Device was evaluated and found to have been missing adhesion between cuff and tube.Manufacturing records show glue and baking process to be within current manufacturing specifications at the time of production.(b)(4).
 
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Brand Name
ULTRA CLEAR LARYNGEAL MASK
Type of Device
LARYNGEAL MASK AIRWAY
Manufacturer (Section D)
TIANJIN KINDWELL MEDICAL EQUIPMENT CO. LTD
nankai district
tianjin 0000
CH  0000
Manufacturer Contact
chuangye rd 1199, jinxian
nanchang city, jiangxi 
MDR Report Key4508110
MDR Text Key5492207
Report Number3009495978-2014-00001
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Type of Report Initial
Report Date 10/06/2014
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? No
Device Operator Health Professional
Device Expiration Date03/19/2019
Device Model Number1036050
Device Catalogue Number1036050
Device Lot Number403016950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2014
Was the Report Sent to FDA? No
Device Age2 MO
Event Location Ambulatory Surgical Facility
Initial Date Manufacturer Received 06/09/2014
Initial Date FDA Received07/02/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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