MAUDE Adverse Event Report: HAINA ACTIVELIFE 1PC-1PC DRAINABLE POUCH W. STOMAHESIVE; POUCH, COLOSTOMY

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

Report received indicates that patient states, she developed a red spotty rash to skin under stomahesive portion of skin barrier 1 week prior to complaint receipt.Appliance change procedure and crusting technique was reviewed with patient.Recommend to clean with water only and not to use any products under skin barrier.Samples sent and patient was advised to call cvt or follow with hcp if no improvement.Patient outcome was not reported.

Manufacturer Narrative

(b)(4).The lot number could not be obtained.A review of the batch record and retain evaluation could not be performed without a lot number.A review of complaint trend for previous 12 months was performed and there are total of (b)(4) complaints of this type for this icc code.There is no objective evidence of nonconformity.

• Brand Name: ACTIVELIFE 1PC-1PC DRAINABLE POUCH W. STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): HAINA; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4121364
• MDR Text Key: 4950110
• Report Number: 9618003-2014-10218
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 09/14/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2014
• 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