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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS BARRIER WITH TAPE BORDER OSTOMY POUCHING SYSTEM

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HOLLISTER INCORPORATED NEW IMAGE CERAPLUS BARRIER WITH TAPE BORDER OSTOMY POUCHING SYSTEM Back to Search Results
Model Number 11203
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Tissue Damage (2104)
Event Date 08/28/2017
Event Type  Injury  
Event Description
It was reported by the user that she started physical therapy which included stretching her abdominal area. The new image ostomy product tape border did not stretch resulting in skin damage consisting of little skin tears. She was experiencing big pimples with yellow crust and red skin under the tape portion of the barrier. Her dermatologist prescribed betamethasone spray for the skin which is helping. She believes her physical therapy and consequent stretching of the skin on her abdomen along with a sensitivity to adhesives caused the issue under the tape.
 
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Brand NameNEW IMAGE CERAPLUS BARRIER WITH TAPE BORDER
Type of DeviceOSTOMY POUCHING SYSTEM
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister drive
libertyville IL 60068
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 Key6866681
MDR Text Key86253064
Report Number1119193-2017-00032
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 08/28/2017,09/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number11203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Home
Date Report to Manufacturer08/28/2017
Date Manufacturer Received08/28/2017
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: 09/14/2017 Patient Sequence Number: 1
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