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U.S. Department of Health and Human Services

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

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HOLLISTER INCROPORATED PREMIER CONVEX FLEXTEND UROSTOMY POUCHING SYSTEM Back to Search Results
Catalog Number 8485
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 02/07/2022
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed for tape border or pouch film causing skin irritation or allergic reaction. Since lot number not provided dhr review not possible. Sample not returned so sample evaluation not possible. Root cause of reported irritation/rash under the film and tape border cannot be determined.
 
Event Description
It was reported that about 1 year ago an end user started experiencing an irritation/rash under the tape border of his ostomy appliance and under the pouch film that touches his skin. He reported that about 1 month ago he went to his doctor about the irritation and the doctor prescribed 0. 1% triamcinolone acetonide cream. He said the doctor believes it to be an allergy. He further reported that the doctor did no more testing and the end user does not have a follow up appointment scheduled with the doctor. The end user continued to report that he is using this cream sparingly and it clears up the area but when he stops using it, the rash returns. End user is working with hollister customer service to try other hollister products to sample.
 
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Brand NamePREMIER CONVEX FLEXTEND UROSTOMY POUCHING SYSTEM
Type of DevicePREMIER CONVEX FLEXTEND 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 Key13694364
MDR Text Key286767982
Report Number1119193-2022-00007
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 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8485
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/04/2022
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: 03/08/2022 Patient Sequence Number: 1
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