MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ACTIVE LIFE PCH STD TAN 32MM; POUCH, COLOSTOMY

Model Number 125340

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Tissue Damage (2104)

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 "he started to have difficulty removing wafer from skin which pulled at his skin.States he has a 1 inch superficial open area to skin at 12 o'clock." applies neosporin ointment to skin.

• Brand Name: ACTIVE LIFE PCH STD TAN 32MM
• 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: 5289359
• MDR Text Key: 33273987
• Report Number: 9618003-2015-40069
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• 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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/27/2016
• Device Model Number: 125340
• Device Lot Number: 1J03024
• 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
• Date Device Manufactured: 09/29/2011
• 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