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

Model Number 022771

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Device manufacturing date: 05/2015.Height: 68 inches.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.(b)(4).

Event Description

End user reports a red rash like area to his peristomal skin from 11 to 3'o clock which extends outward approximately 50mm.He does experience itching from this area after his appliance has been on for a couple of days.End user was prescribed nyamyc powder to use for the skin irritation.

Manufacturer Narrative

After batch record review, no discrepancies were found including non-conformances/deviations were found.There is not enough information to conclude the product did not meet specification and perform as intended.Previous investigation is applicable to this complaint.This previous investigation is closed.Therefore, this complaint will be closed without further action.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 january 12, 2016.(b)(4).

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carr. sanchez, km. 18.5; parque industrial; san cristobal, haina 33102 ; DR 33102
• Manufacturer (Section G): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5134806
• MDR Text Key: 27772104
• Report Number: 9618003-2015-00054
• 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
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/13/2020
• Device Model Number: 022771
• Device Lot Number: 5E00879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: IMODIUM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 59