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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN AND AEROSOL THERAPY; MASK, OXYGEN, NON-REBREATHING
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UNOMEDICAL S.A. DE C.V. OXYGEN AND AEROSOL THERAPY; MASK, OXYGEN, NON-REBREATHING Back to Search Results
Model Number 3106-E
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2014
Event Type  malfunction  
Event Description
It was reported that an oxygen mask had a loose connection where the oxygen tubing connects to the mask.The product was not used on any patient.
 
Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.
 
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Brand Name
OXYGEN AND AEROSOL THERAPY
Type of Device
MASK, OXYGEN, NON-REBREATHING
Manufacturer (Section D)
UNOMEDICAL S.A. DE C.V.
av. industrial falcon secc. 4
lote 7, parque ind. del norte
reynosa, tams. 8873 6
MX  88736
Manufacturer Contact
matthew walenciak, int.assoc.dir.
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4344923
MDR Text Key16851642
Report Number9680866-2014-00043
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/12/2014
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 Expiration Date06/01/2019
Device Model Number3106-E
Device Lot Number104902
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/12/2014
Initial Date FDA Received12/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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