MAUDE Adverse Event Report: CONVATEC, INC ESTEEM SYNERGY 2 PC - 2 PC STOMAHESIVE (DH) WAFER W/ FLEXIBLE COLLAR

Model Number 405457

Device Problem Human-Device Interface Problem (2949)

Patient Problems Skin Discoloration (2074); Skin Tears (2516)

Event Date 04/01/2012

Event Type  Injury  

Event Description

Report received indicated that the patient experienced redness beneath the tape border along with some periods of bleeding.The patient reported first seeing redness in the tape border region two months prior to receipt of complaint after using the product over a period of eight years.The affected area was described as the same dimensions and pattern as the tape collar application.The patient was medically advised to remove the tape collar off the wafer and apply stomahesive powder to the affected area.Patient outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued (b)(4) 2014.Devices listed in this report are used for treatment, not diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: ESTEEM SYNERGY 2 PC - 2 PC STOMAHESIVE (DH) WAFER W/ FLEXIBLE COLLAR
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4057911
• MDR Text Key: 20863254
• Report Number: 1049092-2014-10725
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/01/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 405457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2012
• Initial Date FDA Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 91