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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLEXTEND CUT TO FIT OSTOMY BARRIER

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HOLLISTER INCROPORATED NEW IMAGE FLEXTEND CUT TO FIT OSTOMY BARRIER Back to Search Results
Catalog Number 14604
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Urticaria (2278); Skin Inflammation/ Irritation (4545)
Event Date 01/03/2022
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed over the last 3 years. End user said this is not a lot-specific problem. Since lot number not provided dhr review not possible. Sample not returned so sample evaluation not possible. Patient's race is not known. Root cause of reported skin irritation and itching under the barrier cannot be determined. Hollister is sending samples of a different style of hollister skin barriers (convex) for the end user to try in order to address the report of effluent leakage under the barrier.
 
Event Description
It was reported that an end user who has been using the hollister new image barrier started experiencing irritated, itchy and discolored skin under her barrier in october. She was prescribed nystatin powder and it cleared up. She started experiencing the same thing recently associated with effluent leakage under the barrier. She has been needing to change the barrier more often because of the leakage which is causing some areas under the barrier to bleed. She again started using nystatin powder and the skin is improving.
 
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Brand NameNEW IMAGE FLEXTEND CUT TO FIT OSTOMY BARRIER
Type of DeviceNEW IMAGE FLEXTEND CUT TO FIT OSTOMY BARRIER
Manufacturer (Section D)
HOLLISTER INCROPORATED
2000 hollister drive
libertyville IL 60048 3781
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft VA 24477 9998
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville, IL 60048-3781
8476802170
MDR Report Key13285108
MDR Text Key287402365
Report Number1119193-2022-00002
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14604
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2022
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 Unkown

Patient Treatment Data
Date Received: 01/18/2022 Patient Sequence Number: 1
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