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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC - 1 PC DRAINABLE POUCH; POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC - 1 PC DRAINABLE POUCH; POUCH, COLOSTOMY Back to Search Results
Model Number 022771
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Skin Discoloration (2074)
Event Type  Injury  
Event Description
Per the end user, circumferential red rash under the tape collar of the pouch.Changes pouch every day.Uses ostomy gel with each pouch change and adhesive remover as needed for adhesive buildup.Cleans peristomal skin with soap.No further information is available.
 
Manufacturer Narrative
Convatec is submitting this report as a result of remediation activities related to the fda 483 issued (b)(4) 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.The submission of this report by convatec or related information to the fda and its release by the fda, does not reflect an admission by convatec, or a conclusion by the fda that this report or related information that convatec, their employees, or the convatec device caused or contributed to the reportable event.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.It is noted that there are blank areas on this form, the information was not provided or is unknown.
 
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Brand Name
ACTIVELIFE 1PC - 1 PC DRAINABLE POUCH
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC, INC.
carretera sanchez, km. 18.2
parque industrial itabo, s.a.
san cristobal, haina 3310 2
DR  33102
Manufacturer Contact
matthew walenciak, dir.
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4135814
MDR Text Key4928333
Report Number9618003-2014-10278
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 10/19/2011
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 Expiration Date07/05/2016
Device Model Number022771
Device Lot Number1F03590
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/19/2011
Initial Date FDA Received09/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight66
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