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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT; MASK, OXYGEN, NON-REBREATHING
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TELEFLEX MEDICAL HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT; MASK, OXYGEN, NON-REBREATHING Back to Search Results
Catalog Number 1059
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.However material from the production line was verified and no issues were found that can lead to this customer complaint.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.To perform a proper investigation to confirm the alleged defect and determine a root cause, it is necessary to evaluate the sample involved.If the device becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "the mask works improperly.Leak found during use, at the level of the tube." the device was changed for a new one.There was no report of patient impact or consequence.Patient condition was reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the sample was placed on a nebulizer compressor and tested.During this time no issues were detected.Air was flowing properly.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
 
Event Description
Customer complaint alleges "the mask works improperly.Leak found during use, at the level of the tube." the device was changed for a new one.There was no report of patient impact or consequence.Patient condition was reported as "fine".
 
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Brand Name
HUDSON MASK,NON-REBREATH W/SAFETY VENT,ELONGAT
Type of Device
MASK, OXYGEN, NON-REBREATHING
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7407780
MDR Text Key104876015
Report Number3004365956-2018-00109
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1059
Device Lot Number02L1302800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2018
Date Manufacturer Received05/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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