MAUDE Adverse Event Report: S92S COMBIHESIVE 2 PC - 2 PC DURAHESIVE (DH) C; OSTOMY

Model Number 125903

Device Problem Insufficient Information (3190)

Patient Problems Discomfort (2330); Skin Inflammation (2443)

Event Type  Injury  

Event Description

It was reported that end-user had skin discomfort and developed inflammation under mass/border.Pt outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.The batch record review for lot 1d00214 was performed.No discrepancies were noted in this batch record related to the complaint reported.The retained product was evaluated and the eval results are as follows: the samples were visually inspected and all samples appeared to be in normal condition.Leak testing was performed and passes the established specification.

• Brand Name: S92S COMBIHESIVE 2 PC - 2 PC DURAHESIVE (DH) C
• Type of Device: OSTOMY
• Manufacturer Contact: matthew walenciak, director, ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4059066
• MDR Text Key: 22143493
• Report Number: 9618003-2014-10215
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K855018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/13/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/09/2016
• Device Model Number: 125903
• Device Lot Number: 1D00214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention