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

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

Patient Problems Rash (2033); Skin Discoloration (2074)

Event Date 04/29/2011

Event Type  Injury  

Event Description

Report received indicated the pt experienced a red peristomal rash underneath the entire mass.Pt experienced this condition for an unk period prior to complaint receipt.Pt outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda (b)(4) issued (b)(4) 2014.Device (s) listed in this report is (are) used for treatment, not diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.The retained product was evaluated and the evaluation 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.It is noted that there are blank areas on this form, the info was not provided or is unk.

• Brand Name: ACTIVELIFE 1PC - 1 PC DRAINABLE POUCH W/ STOMAHESIVE(SH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC INC; carretera sanchez, km. 18.2; parque industrial; haine, san cristobal 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4012457
• MDR Text Key: 4955125
• Report Number: 9618003-2014-10013
• 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,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2016
• Device Model Number: 022771
• Device Lot Number: 1B02916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention