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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SA DE CV 3-IN-1 MASK ADULT; MASK, OXYGEN, NON-REBREATHING
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UNOMEDICAL SA DE CV 3-IN-1 MASK ADULT; MASK, OXYGEN, NON-REBREATHING Back to Search Results
Model Number 1635-10
Device Problems Defective Device (2588); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2011
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
Complainant reports "the bush that enables the oxygen nipple and nebuliser bowl to be connected to the mark is not glued in and falls out as the oxygen nipple is being removed" (connector falls off - not glued).
 
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Brand Name
3-IN-1 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
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5209915
MDR Text Key30689087
Report Number9680866-2015-31239
Device Sequence Number1
Product Code KGB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Caregivers
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Caregivers
Device Model Number1635-10
Device Lot Number11-07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2011
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2014
Was Device Evaluated by Manufacturer? Yes
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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