MAUDE Adverse Event Report: CONVATEC INC. C/HESIVE II PLUS FLEX WFR 45MM; PROTECTOR, OSTOMY

Model Number 405101

Device Problems Leak/Splash (1354); Difficult to Remove (1528)

Patient Problems Swelling (2091); Skin Tears (2516)

Event Date 07/16/2014

Event Type  Injury  

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

It was reported that the product was hard to remove, causing leakage and skin lessions.The adhesive, which is located around the plate, sitting so tightly that it is very difficult to get it off.Which gives skin lesions and that the plate releases and causes leakage.

• Brand Name: C/HESIVE II PLUS FLEX WFR 45MM
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5153657
• MDR Text Key: 28435131
• Report Number: 1049092-2015-30553
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• 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: 10/07/2018
• Device Model Number: 405101
• Device Lot Number: 3J02182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2013
• 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