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

Model Number 400598

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

Patient Problem Visual Disturbances (2140)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The end user reported an open area (measuring approximately 22 millimeters) one half inch from her stoma site.The end user sought treatment from her physician and was prescribed cephalexin (500 milligrams, every twelve hours for fourteen days) and was advised to use an over-the-counter antibiotic cream.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No additional pt/event details have been provided to date.Should additional info become available a follow-up report will be submitted.A return sample for eval is not expected.Reported to the fda on (b)(4) 2014.Height: (b)(6).

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE POUCH WITH DUR
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, int asso dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4339694
• MDR Text Key: 5172317
• Report Number: 9618003-2014-00110
• 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: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2014
• 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: Initial
• Patient Sequence Number: 1
• Treatment: ANTIHYPERTENSIVE MEDICATION; IRON; POTASSIUM TAB
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 68