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U.S. Department of Health and Human Services

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

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HOLLISTER INCROPORATED NEW IMAGE CONVEX FLEXTEND CUT TO FIT OSTOMY BARRIER Back to Search Results
Catalog Number 14803
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Urticaria (2278); Skin Inflammation/ Irritation (4545)
Event Date 04/08/2022
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed over the last 3 years. Lot number provided. Device history records reviewed and found to be complete and accurate. Sample not returned so sample evaluation not possible. Root cause of reported skin irritation, blisters, and redness under the barrier and beyond cannot be determined. Hollister is sending samples of a different hollister skin barrier for the end user to try.
 
Event Description
It was reported that an end user experienced pain and redness on her skin after removing her hollister ostomy extended wear barrier that had only been in place for several hours. She reported that the barrier was difficult to remove. She reported that she applied a new barrier but needed to remove it later that day because her skin was burning and itching. She reported that again was difficult to remove and when she removed the barrier, there were blisters and redness on her skin that extended beyond the edges of the barrier. She reported she went to her doctor the next day who said she may be experiencing an allergic reaction, although no allergy testing was done. She reported he prescribed clotrimazole betamethasone (antifungal & corticosteroid) cream to treat the affected area. She said she is seeing slight improvement already. Hollister is sending different barrier products for her to try.
 
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Brand NameNEW IMAGE CONVEX FLEXTEND CUT TO FIT OSTOMY BARRIER
Type of DeviceNEW IMAGE CONVEX 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 Key14209774
MDR Text Key290084943
Report Number1119193-2022-00010
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 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14803
Device Lot Number1F252
Was Device Available for Evaluation? No
Date Manufacturer Received04/13/2022
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: 04/26/2022 Patient Sequence Number: 1
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