MAUDE Adverse Event Report: CONVATEC LIMITED EAKIN COHESIVE SEAL SMALL; PROTECTOR, OSTOMY

Model Number 839002

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problem Tissue Damage (2104)

Event Date 11/01/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Customer called regarding eakin seal and that she was having leakage and bleeding to skin after several wafer changes.Spoke with end user and she reports that she started using new shipment of eakin seals friday and noted they are white in color; thinner; softer; and almost granular looking.She had to change wafer at least 6 times in 24 hours.

Manufacturer Narrative

The report submitted on 10/08/2015, with the patient identifier (b)(6), had the incorrect manufacturer report number 9681410-2015-30377 listed.The correct manufacturer's report number should have been 1000317571-2015-30377.(b)(4).

• Brand Name: EAKIN COHESIVE SEAL SMALL
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; first ave; deeside industrial park; deeside, flintshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; global qarac headquarters; 7900 triad center drive, #400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5311097
• MDR Text Key: 161545418
• Report Number: 1000317571-2015-30377
• Device Sequence Number: 1
• Product Code: EXE
• 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: Lay User/Patient
• Type of Report: Initial,Followup
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/27/2018
• Device Model Number: 839002
• Device Lot Number: 1093577358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2013
• 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
• Patient Outcome(s): Required Intervention