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

Model Number 022757

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

Patient Problems Itching Sensation (1943); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report received indicates that patient developed a "red itchy skin" under tape collar.The area continued to become irritated although the product was removed and changed daily.Prior to receipt of this complaint, the patient used the product for a couple of months without incident.Report also noted that patient was advised to discontinue use and start using an alternative product.Products were sent to the patient for use.Further info regarding outcome of patient 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 listed in this report is used for treatment, not diagnosis.And additional info received regarding this event after filing this report shall be filed on a supplemental mdr.A review of nonconformity related to this complaint investigation was conducted during the initial 12 month reporting period.As a result, there was no evidence that any of the mfg processes and procedures performed at convatec-(b)(4) site contributed to this event.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ STOMAHESIVE (SH)
• 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 Key: 4083786
• MDR Text Key: 21879697
• Report Number: 9618003-2014-10759
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention