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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CUT-TO-FIT FLEXTEND SKIN BARRIER WITHOUT TAPE BORDER OSTOMY BARRIER

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HOLLISTER INCORPORATED NEW IMAGE CUT-TO-FIT FLEXTEND SKIN BARRIER WITHOUT TAPE BORDER OSTOMY BARRIER Back to Search Results
Model Number 15603
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Anemia (1706); Irritation (1941); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
It appears that the user is in the wrong size appliance. Hollister has recommended that the user visit with her stoma nurse for proper evaluation and sizing.
 
Event Description
It was reported by the user that several months ago (she could not remember the month) she was admitted from the er to icu due to blood loss from her stoma. She received 2 units of blood. She said the blood loss was from the edges of the barrier rubbing her stoma. No additional medical treatment was given by the hospital for the bleeding stoma. The user states that she does not know the size of her stoma (she has never seen a stoma nurse) and she can not cut her current barrier large enough to accomodate her stoma.
 
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Brand NameNEW IMAGE CUT-TO-FIT FLEXTEND SKIN BARRIER WITHOUT TAPE 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 Key5704750
MDR Text Key46765860
Report Number1119193-2016-00013
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 05/13/2016,06/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number15603
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 Manufacturer05/13/2016
Date Manufacturer Received05/13/2016
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: 06/07/2016 Patient Sequence Number: 1
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