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

Model Number 022760

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Height: 67 inches.Based on the available information, this event is deemed to be a serious injury.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.A previous investigation is applicable to this complaint.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on february 08, 2016.(b)(4).

Event Description

End user reports that about 6 months ago she developed a red non raised rash under tape collar.She stated that she saw a medical doctor who suspected a fungal infection and prescribed nystop powder to be applied.She reports her skin did not improve with nystop powder, so the doctor decided the skin issue was not fungal and had end user see the wound ostomy continence nurse.Wound ostomy continence nurse performed patch testing and it was determined that end user has an allergic reaction to the tape collar.

• Brand Name: ACTIVELIFE® ONE-PIECE PRE-CUT DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; arque 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: 5417985
• MDR Text Key: 37714506
• Report Number: 9618003-2016-00005
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 86