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

Model Number 400598

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

Patient Problems Skin Erosion (2075); Fluid Discharge (2686)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The end user reported that he has a one year history of open areas above and below the stoma that measure approximately one quarter inch x one inch.He stated that the upper areas appear as punched out holes that are nearly healed, but the lower area looks like the top layer of skin is off and is weeping clear fluid.He treated the area using a small amount of over-the-counter neosporin ointment and covered with duoderm.Add'l info was supplied by the end user on 02/12/2015 which he stated, on (b)(6) 2014 he saw a physician who performed a biopsy on the open area and pyoderma was ruled out.The end user stated he was diagnosed with sweet's syndrome and prescribed betamethasone dipropiomate cream usp 0.05% on (b)(6) 2015.Discussed use of stomahesive powder, crusting the area and use of a hernia belt.The user was also advised to be evaluated by wound ostomy care nurse for the new hernia belt.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.Not add'l pt/event details have been provided to date.Should add'l info become available, a follow-up report will be submitted.

Manufacturer Narrative

Additional information was received on 07/29/2015.No previous investigations are available.After a thorough batch review no discrepancies were discovered.There is not enough information to conclude the patient did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required and the complaint will be closed.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 08/10/2015.

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, interm assoc d ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4534271
• MDR Text Key: 19312010
• Report Number: 9618003-2015-00008
• 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,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 400598
• Device Lot Number: 4H01320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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
• Treatment: ALLEVE; CYMBALTA; REQUIP
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 99