MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 022765

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Reported received indicated the pt experienced itching underneath the adhesive border from the 9 to 12 o'clock position and pinpoint red bumps from the 3 to 6 o'clock position.The pt experienced the condition during an unk period prior to complaint receipt.Pt changes the device every 2 to 7 days, uses reliamed adhesive remover wipes and plain soap and water, safe and simple prep wipes, hollister 7805 adapt ring and occasionally stomahesive powder.Pt advised she will remove adhesive border from device in future.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.(b)(4).Activelife 1 pc - 1 pc drainable pouch w/ stomahesive (sh).A review of complaint trend for previous 12 months was performed and this is the only complaint of this type for this icc code.There is no indication of complaint trend based on this review.No nonconformance or capa relating to the primary reason for contact for this icc were found in the nonconformance reporting sys for the previous 12 months of case creation.(b)(4).

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, dir ; med safety & compliance; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4061122
• MDR Text Key: 16632799
• Report Number: 9618003-2014-10084
• 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: 06/16/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2011
• 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: 42