MAUDE Adverse Event Report: CONVATEC INC. ACTIVE LIFE DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 022771

Device Problems Difficult to Remove (1528); Material Too Rigid or Stiff (1544)

Patient Problems Erythema (1840); Skin Irritation (2076); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

The end user reported that the skin barrier is very stiff and brittle prior to use, and when used remains adhered to the skin.According to the end user, the barrier is then difficult to remove from the skin and leaves the skin red and irritated where the barrier was in contact with the skin.She was seen by the wocn nurse and prescribed nystop powder.

Manufacturer Narrative

A batch record review indicates no discrepancies.The product was manufactured under the appropriate device specification.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according to the appropriate process instructions.The process requirements results were documented in the product batch record.The product was packed and labeled under the appropriate packaging and labeling specification.The bulk item record was reviewed.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according to the appropriate process instruction.The process requirements results were documented in the product batch record.No non-conformances, deviations or discrepancies were found during revision.No further action is required and this issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVE LIFE DRAINABLE POUCH
• 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: 5638046
• MDR Text Key: 44665180
• Report Number: 9618003-2016-00019
• 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,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2020
• Device Model Number: 022771
• Device Lot Number: 5L00820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2015
• 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: 71 YR