MAUDE Adverse Event Report: HOLLISTER INC. NEW IMAGE HIGH OUTPUT DRAINABLE POUCH; OSTOMY POUCHES

Model Number 18013

Device Problem Fluid/Blood Leak (1250)

Patient Problem Skin Irritation (2076)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

Hollister incorporated's new image high output drainable ostomy pouches (b)(4) leaked within 24-48 hrs causing skin irritation.I have been using these pouches for several years and this is becoming a frequent problem.I have reported the issue to hollister on several occasions and requested their quality control person contact me, but have yet to receive any information as to whether they acknowledge the problem or are doing anything to correct it.

• Brand Name: NEW IMAGE HIGH OUTPUT DRAINABLE POUCH
• Type of Device: OSTOMY POUCHES
• Manufacturer (Section D): HOLLISTER INC.
• MDR Report Key: 4277163
• MDR Text Key: 5034015
• Report Number: MW5039231
• 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: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 18013
• Device Catalogue Number: NEW IMAGE HIGH OU
• Device Lot Number: 4/112
• Other Device ID Number: (01)10610075114723(17)190900(3
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2014
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 72