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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SA DE CV OPTI-MIST PLUS TRACHEOBRONCHIAL/ALVEOLAR NEBULISER & KITS; NEBULIZER (DIRECT PATIENT INTERFACE)
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UNOMEDICAL SA DE CV OPTI-MIST PLUS TRACHEOBRONCHIAL/ALVEOLAR NEBULISER & KITS; NEBULIZER (DIRECT PATIENT INTERFACE) Back to Search Results
Model Number 3772MM
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2011
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and 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 "purple valve is defective.No steam.".
 
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Brand Name
OPTI-MIST PLUS TRACHEOBRONCHIAL/ALVEOLAR NEBULISER & KITS
Type of Device
NEBULIZER (DIRECT PATIENT INTERFACE)
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 Key5208017
MDR Text Key30636151
Report Number9680866-2015-31235
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
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 Received11/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number3772MM
Device Lot Number10-23
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2014
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 Unknown
Patient Sequence Number1
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