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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE CERAPLUS TAPE BORDERED CUT TO FIT BARRIER

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HOLLISTER INCROPORATED NEW IMAGE CERAPLUS TAPE BORDERED CUT TO FIT BARRIER Back to Search Results
Catalog Number 11203
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 07/01/2022
Event Type  Injury  
Event Description
It was reported that a new ostomate went to the ed one day after she started experiencing skin irritation that was hot, painful and prickly under the barrier and tape portion of a hollister new image barrier. She reported that the skin had blisters that broke open and were bleeding. She reported that the ed said it was an allergic reaction and a skin infection. She further reported that she was given prednisone in the ed and was sent home on prednisone, keflex, benadryl and pepcid. She reports that now, a week later, she is using a barrier product that is tapeless and the skin is improving.
 
Manufacturer Narrative
Trend analysis conducted and no other complaints for this sku and lot number found. Device history record (dhr) review conducted based upon the lot number provided and the records were found to be complete and accurate. Sample not returned so sample evaluation not possible. Root cause of reported skin irritation under the ostomy barrier and tape cannot be determined.
 
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Brand NameNEW IMAGE CERAPLUS TAPE BORDERED CUT TO FIT BARRIER
Type of DeviceNEW IMAGE CERAPLUS TAPE BORDERED 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 Key15013162
MDR Text Key295863976
Report Number1119193-2022-00024
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 Non-Healthcare Professional
Type of Report Initial
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number11203
Device Lot Number2D142
Was Device Available for Evaluation? No
Date Manufacturer Received07/07/2022
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: 07/14/2022 Patient Sequence Number: 1
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