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U.S. Department of Health and Human Services

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

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ACTIVE LIFE 1-PC CAP 19MM (1X30PK) US POUCH, COLOSTOMY Back to Search Results
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.
 
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Brand NameACTIVE LIFE 1-PC CAP 19MM (1X30PK) US
Type of DevicePOUCH, COLOSTOMY
MDR Report Key6431081
MDR Text Key70751007
Report Number9618003-2017-00002
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number175611
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/10/2017
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

Patient Treatment Data
Date Received: 03/24/2017 Patient Sequence Number: 1
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