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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL SA DE CV NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)
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UNOMEDICAL SA DE CV NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE) Back to Search Results
Model Number 1638-00
Device Problems Defective Device (2588); Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 08/21/2013
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 21 cfr 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 inner stem fell out of the nebulizer and the nebulizer was not able to be connected and stay attached.".
 
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Brand Name
NEBULIZER
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 Key5197187
MDR Text Key30230774
Report Number9680866-2015-31220
Device Sequence Number1
Product Code CAF
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 distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2014
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 No Information
Device Model Number1638-00
Device Lot Number12-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2013
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/27/2014
Initial Date FDA Received11/03/2015
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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