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

Model Number 022771

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Skin Irritation (2076); Blood Loss (2597)

Event Type  malfunction  

Event Description

An end user reported the hole she cut on the device to fit around her stoma caused bleeding when it rubs against her skin.On (b)(6) 2015 she presented to the hospital for persistent bleeding through her stoma.End user estimates the amount of blood to be about half a cup.During her hospitalization she was administered an anticoagulant (unknown name) subcutaneously.On (b)(6) 2015, she was discharged from the hospital.She states still experiences bleeding intermittently especially when she is moving around; symptoms improve while lying down.A moldable one piece device was sent out to end user; so that she will not need to cut the device.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE CUT-TO-FIT POUCH
• Manufacturer (Section D): CONVATEC , INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, interim assoc. ; 211 american avenue; greensboro, NC 27409 ; 9073779293
• MDR Report Key: 4865030
• MDR Text Key: 20368420
• Report Number: 9618003-2015-00031
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2015
• 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
• Treatment: MEDICATIONS: BLOOD THINNERS (UNKNOWN NAME)
• Patient Age: 77 YR