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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
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UNOMEDICAL S.A. DE C.V. OXYGEN AND AEROSOL THERAPY; MASK, OXYGEN Back to Search Results
Model Number I002610
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2014
Event Type  malfunction  
Event Description
Reporter states "connected the blue dilator with the device and increased the oxygen flow slowly.Soon the dilator disconnected from the device.".
 
Manufacturer Narrative
Based on the available info, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional info 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
Manufacturer (Section D)
UNOMEDICAL S.A. DE C.V.
av. industrial falcon, lote 7
parque ind. del norte
reynosa, tamaulipas 8873 6
MX  88736
Manufacturer Contact
matthew walenciak
211 american avenue
interim associate director
greensboro, NC 27409
9083779293
MDR Report Key4340443
MDR Text Key5202300
Report Number9680866-2014-00044
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
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 11/11/2014
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 Model NumberI002610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/11/2014
Initial Date FDA Received12/10/2014
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 Initial
Patient Sequence Number1
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