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

Model Number 125330

Device Problem Insufficient Information (3190)

Patient Problem Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.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 october 13,2015 (b)(4).

Event Description

End user reports she developed two ulcers under the mass 3 months ago.One ulcer measures 1 inch by an eighth of an inch at 12 o'clock peristomal skin and the other ulcer measures a few centimeters to 6 o'clock peristomal area.She sought treatment from her physician who prescribed oral zovirax and cephalexin 500mg three times a day for 14 days.She states she will crust the affected area with stomahesive powder and barrier wipes.End user also states she has noticed some improvement to ulcers since beginning the prescribed medications.

Manufacturer Narrative

No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.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 august 18, 2016.(b)(4).

• Brand Name: ACTIVELIFE® ONE-PIECE DRAINABLE 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5147319
• MDR Text Key: 28141208
• Report Number: 9618003-2015-00056
• 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: Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• 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: 69 YR