MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE® ONE-PIECE DRAINABLE PRE-CUT POUCH; POUCH, COLOSTOMY

Model Number 125339

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

Patient Problems Skin Irritation (2076); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Additional information was requested.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on november 12, 2015.

Event Description

End user reports he developed red weeping skin under tape collar of pouch about 2 months ago.The end user stated that it is a mirror image of the tape portion of the wafer and involves 100% of tape portion but, does not include the area under mass.It was further stated that "this issue has not resolved or worsened." end user reports seeing a dermatologist and received a prescription for betamethasole valerate 0.12% topically in which he used for several days with no improvement.End user does not recall a diagnosis.

• Brand Name: ACTIVELIFE® ONE-PIECE DRAINABLE PRE-CUT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; arque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer (Section G): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5220870
• MDR Text Key: 31053271
• Report Number: 9618003-2015-00062
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 125339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR