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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED HOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE HOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE

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HOLLISTER INCROPORATED HOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE HOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE Back to Search Results
Catalog Number 8481
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Urticaria (2278)
Event Date 09/08/2021
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed. Since lot number not provided a dhr review not possible. Sample not returned so sample evaluation not possible. Root cause of reported rash under the barrier cannot be determined.
 
Event Description
It was reported that an end user who was using the hollister premier ostomy appliance developed skin irritation, redness and itching under her barrier. The doctor prescribed nystatin pills and cream. That helped a little, but then the barrier would not adhere. She will be asking her doctor for nystatin powder. In addition, hollister will send her a different formulation of hollister's ostomy barriers without a tape border to see if that improves her skin.
 
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Brand NameHOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE
Type of DeviceHOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE
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 Key13002708
MDR Text Key285085194
Report Number1119193-2021-00039
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 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8481
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2021
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: 12/14/2021 Patient Sequence Number: 1
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