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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE, CUT TO FIT OSTOMY BARRIER

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HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE, CUT TO FIT OSTOMY BARRIER Back to Search Results
Model Number 14803
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941); Skin Tears (2516)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
The dhr for lot 6k082 was reviewed and found to be complete and accurate. It appears the individual might be allergic to a component in the tape border.
 
Event Description
It was reported by the patient, that she developed red itchy skin under the tape portion of the barrier. The irritation continued and started resulting in skin stripping. Her doctor prescribed triamcinolone 0. 1% cream which she is applying twice a day by removing her appliance. Based on her doctor's recommendation she will also try otc benadryl. She has allergies to pcn and environmental allergies. She has not yet seen a wocn.
 
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Brand NameNEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE, CUT TO FIT
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 Key6538195
MDR Text Key74212363
Report Number1119193-2017-00018
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 04/07/2017,05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number14803
Device Lot Number6K082
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 Manufacturer04/07/2017
Date Manufacturer Received04/07/2017
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: 05/02/2017 Patient Sequence Number: 1
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