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); Fluid Discharge (2686)

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.Date of event: (b)(6) 2015.Patient height: 68 inches.(b)(4).

Event Description

The end user reported he developed a red, itchy, and weepy rash under the pouch film.The rash has persisted for approximately one week.After an examination, the end user's physician prescribed an antifungal powder (nystatin).The end user noted she has not seen any improvement to the area since using the antifungal powder.The physician reportedly suspected an allergic reaction.No further information was provided.

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.; lot 30 - piisa industrial park; carretera sanchez km. 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5114662
• MDR Text Key: 27173474
• Report Number: 9618003-2015-00052
• 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: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• 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
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 69