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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SDN BHD LARYNGEAL AIRWAY, STANDARD; LARYNGEAL MASK
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UNOMEDICAL SDN BHD LARYNGEAL AIRWAY, STANDARD; LARYNGEAL MASK Back to Search Results
Model Number MM65220050
Device Problem Hole In Material (1293)
Patient Problem No Patient Involvement (2645)
Event Date 10/30/2014
Event Type  malfunction  
Event Description
The end user stated the straight laryngeal mask has a hole in the cuff.
 
Manufacturer Narrative
Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.No add'l pt/event details have been provided to date.Should add'l info become available, a follow up report will be submitted.
 
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Brand Name
LARYNGEAL AIRWAY, STANDARD
Type of Device
LARYNGEAL MASK
Manufacturer (Section D)
UNOMEDICAL SDN BHD
bakar arang industrial estate
sungai petani, kedah 0800 0
MY  08000
Manufacturer Contact
matthew walenciak, interim associ
211 american ave
greensboro, NC 27409
9083779293
MDR Report Key4321976
MDR Text Key18734293
Report Number9611710-2014-00387
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/03/2014
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 Date10/01/2014
Device Model NumberMM65220050
Device Lot Number54219R004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2014
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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