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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE TRANSPARENT SKIN BARRIER WITH ADHESIVE BORDER OSTOMY BARRIER

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HOLLISTER INCORPORATED NEW IMAGE TRANSPARENT SKIN BARRIER WITH ADHESIVE BORDER OSTOMY BARRIER Back to Search Results
Model Number 14603
Device Problem Insufficient Information (3190)
Patient Problems Inflammation (1932); Rash (2033); Reaction (2414)
Event Date 04/01/2016
Event Type  Injury  
Manufacturer Narrative
There was no evidence of device malfunction; customer reports an allergic reaction to barrier. Biocompatibility testing in accordance with iso 10993 has been successfully completed on the barrier material.
 
Event Description
It was reported by the user that she had an ileostomy in (b)(6) of 2015 and was given a new image flextend barrier to use. A couple months following her ileostomy the area of skin over her stoma became "rashy". The inflammation was persistent and by (b)(6) or (b)(6) of 2016 the area had gotten deeper and started weeping and had a small amount of blood. On (b)(6) 2016 she had a biopsy of the area and it was determined that she had an allergic reaction to the barrier material.
 
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Brand NameNEW IMAGE TRANSPARENT SKIN BARRIER WITH ADHESIVE BORDER
Type of DeviceOSTOMY BARRIER
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister dr
libertyville IL 60048
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft VA 24477 9998
Manufacturer Contact
anne riba
2000 hollister dr
libertyville, IL 60048
8476805625
MDR Report Key5851543
MDR Text Key51339982
Report Number1119193-2016-00019
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 07/13/2016,08/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number14603
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Home
Date Report to Manufacturer07/13/2016
Date Manufacturer Received07/13/2016
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 Initial

Patient Treatment Data
Date Received: 08/05/2016 Patient Sequence Number: 1
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