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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SA DE CV NON-REBREATHER OXYGEN MASK, ADULT; MASK, OXYGEN, NON-REBREATHING
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UNOMEDICAL SA DE CV NON-REBREATHER OXYGEN MASK, ADULT; MASK, OXYGEN, NON-REBREATHING Back to Search Results
Model Number 108MM
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.No patient harm was reported.Additional details have been requested but not provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).
 
Event Description
Complaint received from a distributor reporting that "the tube break off from the mask after 2 or 3 days of use." the issue was noted at the fixation between the mask and the tube.No further information has been provided.
 
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Brand Name
NON-REBREATHER OXYGEN MASK, ADULT
Type of Device
MASK, OXYGEN, NON-REBREATHING
Manufacturer (Section D)
UNOMEDICAL SA DE CV
av. industrial falcon lote 7
parque ind del norte
reynosa, tamaulipas 88736
MX  88736
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key5783861
MDR Text Key49237661
Report Number9680866-2016-00084
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 06/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number108MM
Was Device Available for Evaluation? No
Date Manufacturer Received06/17/2016
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
Type of Device Usage Unknown
Patient Sequence Number1
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