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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVLIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH) PLUS; POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC, INC. ACTIVLIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH) PLUS; POUCH, COLOSTOMY Back to Search Results
Model Number 400599
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Burning Sensation (2146)
Event Date 04/05/2012
Event Type  Injury  
Event Description
Report received indicated that the first time the pt applied the 1 piece pouch there was a little itching and burning sensation under the mass only.When the appliance was changed the next day, the pt felt a greater degree of itching and burning and had to remove the new appliance after one day of wear.The skin was splotchy, red, dry and burning, especially at the bottom and both side under the mass only.No further info was provided and the pt outcome was not reported.
 
Manufacturer Narrative
Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.A lot number could not be obtained therefore a review of the batch record data could not be performed without a valid lot number.(b)(4).No events or capas relating to the complaint issue were found in the global non-conformance reporting system for the previous 12 months of case creation.It is noted that there are blank areas on this form, the info was not provided or is unk.
 
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Brand Name
ACTIVLIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH) PLUS
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC, INC.
carr. sanchez, km. 18.5
parque industrial
san cristobal, haina 3310 2
DR  33102
Manufacturer Contact
matthew walenciak, director
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4059045
MDR Text Key19087317
Report Number9618003-2014-10601
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K833625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/10/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number400599
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/10/2012
Initial Date FDA Received08/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight126
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