MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ACTIVE LIFE PCH STD CLR 19MM; POUCH, COLOSTOMY

Model Number 022764

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

Patient Problem Tissue Damage (2104)

Event Date 11/05/2011

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Complaintant reports "has skin tearing apart after 2 weeks of use of the product.Skin is tearing not only at the tape border, but also at the top of tape border, and also under palstic of the pouch.Did not see any doctor or nurse.Was using cortisone cream.Also was applying stomahesive powder that she had for 7 years.".

• Brand Name: ACTIVE LIFE PCH STD CLR 19MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC; 18.5 parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5289315
• MDR Text Key: 33273612
• Report Number: 9618003-2015-40066
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• 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 Number: 1