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

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

Patient Problems Irritation (1941); Rash (2033)

Event Date 08/11/2011

Event Type  Injury  

Event Description

Report received from the end user states that she experienced itching under the border for four months.The end user has always purchased the same product and the itching under the border has never happened before.The pt's subsequent outcome was not reported.

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.The batch record review for lot 0f03900 was performed.No discrepancies were noted in these batch records 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.A review of complaint trend for previous 12 months was performed and there are total of 8 complaints of this type for this lot was received.No non-conformance or capas relating to the primary reason for contact for this icc were found in the non-conformance reporting system for the previous 12 months of case creation.

• Brand Name: ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/STOMAHESIVE (SH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial; haina, san cristobal 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4071692
• MDR Text Key: 17614839
• Report Number: 9618003-2014-10171
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/12/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/26/2015
• Device Model Number: 022771
• Device Lot Number: 0F03900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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
• Patient Age: 75 YR