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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACTIVELIFE; POUCH, COLOSTOMY
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ACTIVELIFE; POUCH, COLOSTOMY Back to Search Results
Model Number 022771
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Discoloration (2074)
Event Type  Injury  
Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.  to date no additional information has been received.Should additional information become available, a follow-up report will be submitted.  (b)(4).
 
Event Description
End user reports red skin under tape collar to the right side of the wafer which started approximately a couple months ago.Prior to this end user developed an unrelated staph infection to legs which moved to abdomen and underneath tape collar.She was prescribed bactrim for the staph infection and is now taking prescription cephalexin capsule for the red skin under the tape collar.She reports there is some lessening to the redness under the tape collar.The doctor was uncertain if the issue is related to the staph infection or to the adhesive on the tape collar.Additionally, it was reported that the end user stated that the red skin started on the right side of the wafer at the same time as the staph infection on the legs.No pictures were provided and no further details have been provided.
 
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Brand Name
ACTIVELIFE
Type of Device
POUCH, COLOSTOMY
MDR Report Key6606214
MDR Text Key76479119
Report Number9618003-2017-00001
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 Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number022771
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/24/2017
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age34 YR
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