MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC COLODRESS+ PCH CLD STD TAN 38MM; POUCH, COLOSTOMY

Model Number 403816

Device Problem Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Date 06/29/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

The mass adhere very strongly.It's very difficult to remove it.Pain on removal.

• Brand Name: COLODRESS+ PCH CLD STD TAN 38MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC; inc.: carr. sanchez, km. 18.5; parque industrial, haina; san cristobal, 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5153708
• MDR Text Key: 28414712
• Report Number: 9618003-2015-30561
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/03/2018
• Device Model Number: 403816
• Device Lot Number: 3H02780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2013
• 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