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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX MICROLARYNGEAL TUBE, IVORY, ORAL/NASAL, PRO; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
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NULL PORTEX MICROLARYNGEAL TUBE, IVORY, ORAL/NASAL, PRO; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Back to Search Results
Catalog Number 100/222/400
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/05/2021
Event Type  malfunction  
Event Description
It was reported that the lma used, shows a manufacturing defect by bulging of one side, which will not seal the airway and the possibility of aspiration will increase.No patient injury was reported.
 
Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.Dhr: a device history review was also conducted on the component lot numbers and no discrepancies were found.
 
Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.Dhr: a device history review was also conducted on the component lot numbers and no discrepancies were found.
 
Event Description
It was reported that the lma used, shows a manufacturing defect by bulging of one side, which will not seal the airway and the possibility of aspiration will increase.No patient injury was reported.
 
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Brand Name
PORTEX MICROLARYNGEAL TUBE, IVORY, ORAL/NASAL, PRO
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
Manufacturer (Section G)
NULL
MDR Report Key13579147
MDR Text Key286119210
Report Number3012307300-2022-03443
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeKU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2022
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 Catalogue Number100/222/400
Device Lot Number20190212061
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/05/2021
Initial Date FDA Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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