MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE® ONE-PIECE DRAINABLE PRE-CUT; POUCH, COLOSTOMY

Model Number 022764

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.

Event Description

End user reports circumferential red, raw and weeping peristomal skin under the white tape collar for past 1 1/2 months.She said the area is painful and itches at times.She reports seeing three different doctors.The first doctor prescribed topicort ointment; the second doctor prescribed clotrimazole betamethasone, and the third doctor prescribed olux-e foam to the affected area.She said he also diagnosed her with an allergic reaction to the white tape collar.

• Brand Name: ACTIVELIFE® ONE-PIECE DRAINABLE PRE-CUT
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; parque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5957093
• MDR Text Key: 54953868
• Report Number: 9618003-2016-00047
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ALLKARE ADHESIVE REMOVER; AMLODIPINE; BABY ASPIRIN; GABAPENTIN; LOVASTATIN; PROLIA; PROTECTIVE BARRIER WIPES(NAME NOT PROVIDED); RESTASIS; VICODIN; VITAMIN D3; ZOLPIDEM
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 73