MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1 PC DRAINABLE POUCH W/DURAHESIVE; POUCH, COLOSTOMY, 78

Model Number 175785

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problems Discharge (2225); Skin Inflammation (2443)

Event Date 06/18/2014

Event Type  Injury  

Event Description

It is reported that the end-user developed redness with intermittent weeping and oozing to the peristomal skin which began before undergoing hernia surgery on (b)(6) 2014.This issue was evaluated by the wound ostomy & continence nurse (wocn) during end-user's hospital stay, and it was determined that this issue was related to the large sized hernia and use of convexity.It is further reported that there has been intermittent leaking of the wafer being used resulting from loose stools and poor seal around stoma.Lastly, an antifungal powder medication was prescribed by physician which end-user have been using for two (2) weeks since surgery and now stoma is flat and slightly (b)(6).

Manufacturer Narrative

Based on the avail info, this event is deemed to be a serious injury.End-user was advised of the following skin care plan: perform crusting techniques with the use of stomahesive powder and protective barrier wipes, try eakins cohesive seals as barrier; discontinue use convexity currently due to mesh implanted during hernia repair, and to notify convatec of any questions, concerns and if condition persists.Lastly, convatec will send flat moldable wafers for end-user currently has pouches and eakins.No add'l pt/event details have been provided to date.A return sample for eval is not expected.Should add'l info become available, a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVELIFE 1 PC DRAINABLE POUCH W/DURAHESIVE
• Type of Device: POUCH, COLOSTOMY, 78
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, assoc. dir., ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4088901
• MDR Text Key: 21445937
• Report Number: 1049092-2014-00381
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 175785
• Device Catalogue Number: 175785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2014
• 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 Weight: 98