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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL LARYNGEAL-TUBE; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
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NULL LARYNGEAL-TUBE; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Back to Search Results
Catalog Number 32-05-004
Device Problem Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2020
Event Type  malfunction  
Event Description
It was reported that after subjecting the newly purchased product to pre-use autoclave sterilization, the customer noticed its one-way valve cover became melted.No patient injury was reported.
 
Manufacturer Narrative
Manufacturing site address is unknown.D4: udi information is unknown.Premarket (510k) number is unknown.The device history record (dhr) is at the supplier.A product sample was received for evaluation by the supplier.The root cause is unknown; the evaluation was done by the supplier.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
 
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Brand Name
LARYNGEAL-TUBE
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
Manufacturer (Section G)
NULL
MDR Report Key15353890
MDR Text Key302445523
Report Number3012307300-2022-17698
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/04/2022
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 Other
Device Catalogue Number32-05-004
Device Lot Number425921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/20/2022
Initial Date FDA Received09/04/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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