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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER CONVEX FLEXTEND TAPE BORDERED UROSTOMY POUCHING SYSTEM

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HOLLISTER INCROPORATED PREMIER CONVEX FLEXTEND TAPE BORDERED UROSTOMY POUCHING SYSTEM Back to Search Results
Catalog Number 84794
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 04/26/2021
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed for rash under the barrier. Since lot number not provided dhr review not possible. No evidence that this a is lot-specific issue. 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 started developing a rash under the barrier of his hollister ostomy barrier about one year ago. The end user reported that it is a minor inconvenience which they manage by use of nystatin powder prescribed by his doctor. He reported that he uses the nystatin powder on and off whenever he experiences the rash. Hollister customer service is sending him other products to trial.
 
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Brand NamePREMIER CONVEX FLEXTEND TAPE BORDERED UROSTOMY POUCHING SYSTEM
Type of DevicePREMIER CONVEX FLEXTEND TAPE BORDERED UROSTOMY POUCHING SYSTEM
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 Key14277761
MDR Text Key294618240
Report Number1119193-2022-00013
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 05/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number84794
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/22/2022
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: 05/04/2022 Patient Sequence Number: 1
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