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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER

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HOLLISTER INCROPORATED NEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER Back to Search Results
Catalog Number 11704
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 04/17/2022
Event Type  Injury  
Event Description
It was reported that an end user started developing a rash and oozing under the hollister ostomy skin barrier after using these products for 5 months. She reported that the rash spread to most of her body. She stated her doctor prescribed triamcinolone ointment and keflex for 7 days. She said the rash had not fully resolved so she was placed on oral prednisone and will see a wocn. She has since switched to a different hollister ostomy barrier and she reported it does not seem to cause this reaction.
 
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed. Device history records reviewed for the lot number provided and found to be complete and accurate. Sample not returned so sample evaluation not possible. Root cause of reported reaction to the ostomy barrier cannot be determined.
 
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Brand NameNEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER
Type of DeviceNEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT 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 Key14428816
MDR Text Key291945838
Report Number1119193-2022-00017
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 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number11704
Device Lot Number2B192
Was Device Available for Evaluation? No
Date Manufacturer Received05/10/2022
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: 05/18/2022 Patient Sequence Number: 1
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