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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC W/O TUBING,ELONG,ADULT; MASK, OXYGEN
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TELEFLEX MEDICAL HUDSON MASK,MEDIUM CONC W/O TUBING,ELONG,ADULT; MASK, OXYGEN Back to Search Results
Catalog Number 1049
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "mask oxygen connection does not connect properly to oxygen tubing.Tubing easily falls off mask.New mask in use, oxygen tubing remains consistent.".
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.It was also found that additional oxygen tubing that is not part of the finished good was re turned.During the visual exam it was observed that the oxygen tubing is easily disconnected from the grommet.The grommet that is assembled on the received mask was found within dimensional specification.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.
 
Event Description
The complaint is reported as: "mask oxygen connection does not connect properly to oxygen tubing.Tubing easily falls off mask.New mask in use, oxygen tubing remains consistent.".
 
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Brand Name
HUDSON MASK,MEDIUM CONC W/O TUBING,ELONG,ADULT
Type of Device
MASK, OXYGEN
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8848282
MDR Text Key152905247
Report Number3004365956-2019-00200
Device Sequence Number1
Product Code BYG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1049
Device Lot Number74A1901535
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2019
Date Manufacturer Received08/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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