MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/STOMAHESIVE (SH)

Model Number 022754

Device Problem Human-Device Interface Problem (2949)

Patient Problems Skin Discoloration (2074); Skin Irritation (2076)

Event Type  Injury  

Event Description

Report received indicated the pt experienced red, peeling, non-weeping skin underneath the adhesive border, with a brown area at the 12 o'clock position.The pt experienced the condition during a period of one week prior to complaint receipt.Pt now uses better life belt to secure device.Pt outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued 04/16/2014.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.A review of complaint trend for previous 12 months was performed and this is the only complaint of this type for this lot was received.There is no indication of complaint trend based on this review.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/STOMAHESIVE (SH)
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial; haina,san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; grfeensboro, NC 27409 ; 9083779293
• MDR Report Key: 4053738
• MDR Text Key: 4902961
• Report Number: 9618003-2014-10088
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• 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: 06/21/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/21/2010
• Device Model Number: 022754
• Device Lot Number: 5L0948N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80