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U.S. Department of Health and Human Services

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

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CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1 PC - 1PC DRAINABLE POUCH W/STOMAHESIVE (SH); POUCH, COLOSTOMY Back to Search Results
Model Number 022771
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Type  Injury  
Event Description
Report received indicated that the patient had a rash.This trackwise record was created to cover the rash issue mentioned in record number 213668.No further information was provided and the patient 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 additional information received regarding this event after filing this report shall be filed on a supplemental mdr.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.It is noted that there are blank areas on this form, the information was not provided is unknown.
 
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Brand Name
ACTIVELIFE 1 PC - 1PC DRAINABLE POUCH W/STOMAHESIVE (SH)
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 (Section G)
CONVATEC DOMINICAN REPUBLIC, INC.
carretera sanchez, km. 18.2
parque industrial itabo, s.a.
san cristobal, haina
DR  
Manufacturer Contact
matthew walenciak, director
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4072199
MDR Text Key4897119
Report Number9618003-2014-10904
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K833625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/27/2012
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 Expiration Date11/02/2016
Device Model Number022771
Device Lot Number1K02966
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/27/2012
Initial Date FDA Received08/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2012
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;
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