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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE; POUCH COLOSTOMY

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CONVATEC, INC. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE; POUCH COLOSTOMY Back to Search Results
Model Number 175780
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Itching Sensation (1943); Skin Irritation (2076)
Event Type  Injury  
Event Description
Patient reported circumferential redness and multiple fluid filled areas under the entire mass of her device.End-user explained she developed an itch and area became sore upon touch as the climate temperature increased.Patient used adhesive powder to the peristomal area and used a drainable pouch with stoma adhesive skin barrier.Patient was recommended by health professional to continue to apply neutralizing agent to her peristomal skin until the breakdown resolved.The end user subsequent outcome was not reported.
 
Manufacturer Narrative
Convatec is submitting this report as a result of remediation activities related to the fda 482 issued april 16, 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.Activelife convex 1-piece pre-cut drainable pouch w/durahesive skin barrier w/1-sided comfort panel and tape collar 12" transparent.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(6) 2011.The data presented is from three different product applications.The report states that there are no significant trends.
 
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Brand Name
ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE
Type of Device
POUCH COLOSTOMY
Manufacturer (Section D)
CONVATEC, INC.
211 american ave.
greensboro NC 27409
Manufacturer Contact
matthew walenciak, director
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4147532
MDR Text Key4770538
Report Number1049092-2014-11754
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 06/18/2013
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 Number175780
Device Lot Number3A01085
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/18/2013
Initial Date FDA Received09/19/2014
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
Patient Outcome(s) Other;
Patient Weight82
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