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U.S. Department of Health and Human Services

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

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CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 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 Itching Sensation (1943); Rash (2033)
Event Date 04/02/2012
Event Type  Injury  
Event Description
Report received indicated that the pt developed an itchy red rash under the region located between the eakin seal and the tape border area.Report also noted that the fluid in the blister initially appeared bloody and it has now developed into a "bumpy sometimes moist rash".Prior to the receipt of this complaint, the pt used the product for over five years without incident.Courses of treatment prescribed include various mediated powder.If the symptoms progress, pt will seek further treatment from her dermatologist.Further info regarding pt outcome was not available.
 
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 additional info received regarding this event after filing this report shall be filed on a supplemental mdr.A review of nonconformances related to this complaint investigation was conducted during the initial 12 month reported period.As a result there was no evidence that any of the manufacturing processes and procedures performed contributed to this event.
 
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Brand Name
ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/DURAHESIVE (DH) PLUS
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 Key4071694
MDR Text Key20454626
Report Number9618003-2014-10751
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K780454
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 06/14/2012
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/14/2012
Initial Date FDA Received08/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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