MAUDE Adverse Event Report: ACTIVE LIFE 1-PC CAP 19MM (1X30PK) US; POUCH, COLOSTOMY

Model Number 175611

Device Problem Device Handling Problem (3265)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.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.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional patient/event details have been requested but none have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

The end user reported that in (b)(6) 2017, he removed a stoma cap ½ hour after applying, and noted his stoma was bleeding.It was reported that the end user believes this is related to not cutting the opening to the correct size and the mass cutting into the stoma; however, he did not note any cuts to the stoma.The end user held pressure to the area with a towel for 1-2 minutes and the bleeding stopped.He then applied his usual wafer without any further issues or bleeding.No photographs were available.

• Brand Name: ACTIVE LIFE 1-PC CAP 19MM (1X30PK) US
• Type of Device: POUCH, COLOSTOMY
• MDR Report Key: 6431081
• MDR Text Key: 70751007
• Report Number: 9618003-2017-00002
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175611
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR