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

Model Number 839005

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

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

End-user reports circumferential peristomal redness under the eakin cohesive seal.Reports effluent starts to ooze under eakin cohesive seal within hours of application causing this peristomal redness.He also reports eakin seals are difficult to remove and that 1 was so difficult to remove that he stripped his skin when removing it and as a result he had a small amount of bleeding from this area.No bleeding noted at this time.He said he is unable to use any sh powder.Instructed on cleansing his peristomal skin with water and mild soap; one without lotions; moisturizers or creams.Instructed if area does not improve or he has any questions to contact us for additional instructions.

Manufacturer Narrative

The report submitted on 12/11/2015, with the patient identifier (b)(6) had the incorrect manufacturer report number 9681410-2015-40087 listed.The correct manufacturers report number should have been 1000317571-2015-40087.(b)(4).

• Brand Name: EAKIN COHESIVE SEAL SLIM
• 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: 5311319
• MDR Text Key: 161545752
• Report Number: 1000317571-2015-40087
• 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: 11/06/2015

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: No Information
• Device Expiration Date: 02/01/2017
• Device Model Number: 839005
• Device Lot Number: 1093576627
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/19/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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