MAUDE Adverse Event Report: CONVATEC ACTIVE LIFE 1 PIECE DRAINABLE POUCH; OSTOMY POUCH

Model Number 22771

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 09/10/2016

Event Type  malfunction  

Event Description

I am a colostomy patient.The hospital i had been affiliated with, (b)(6), changed suppliers.The company, (b)(4) provides products that are either very old or inferior.There is absolutely no adhesive on the stoma pouches.I have had my colostomy for almost 3 years, and never had a problem until they switched suppliers.

• Brand Name: ACTIVE LIFE 1 PIECE DRAINABLE POUCH
• Type of Device: OSTOMY POUCH
• Manufacturer (Section D): CONVATEC
• MDR Report Key: 6036249
• MDR Text Key: 57870290
• Report Number: MW5065466
• Device Sequence Number: 1
• Product Code: EZQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22771
• Device Lot Number: 6B03583
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CONVATEC ACTIVE LIFE POUCH; PANTOPRAZOLE; RX MEDS: BUDESONIDE
• Patient Age: 48 YR
• Patient Weight: 63