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

Model Number 022761

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 07/05/2012

Event Type  Injury  

Event Description

The pt reported he developed a red, itchy rash under the tape collar of the device.The rash has persisted for approximately 4 months.The pt sought med treatment.The pt was allegedly advised the rash was not a yeast infection but appeared to be an allergic reaction.The pt has discontinued use of a number of products but has been unable to determine the cause of the allergy.No additional info was provided.

Manufacturer Narrative

Analysis is taken from a trending report of evaluation 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.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.

• Brand Name: ACTIVELIFE 1-PIECE PRE-CUT DRAINABLE POUCH W/ STOMAHESIVE (SH) SKIN BARRIERS W/
• 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 ; med safety & compliance; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4125023
• MDR Text Key: 16856278
• Report Number: 9618003-2014-11051
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/05/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2012
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other