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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER CONVEX UROSTOMY POUCH WITH PRE-SIZED BARRIER

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HOLLISTER INCROPORATED PREMIER CONVEX UROSTOMY POUCH WITH PRE-SIZED BARRIER Back to Search Results
Catalog Number 8483
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278)
Event Date 08/20/2021
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed. Since lot number not provided dhr review not possible. Sample not returned so sample evaluation not possible. Patient's age, gender, weight and race not known. Root cause of reported peristomal skin rash cannot be determined.
 
Event Description
It was reported that a patient was using hollister pre-cut urostomy pouch and experienced a peristomal rash. He was treated with dakin solution for cleaning, then triamcinolone spray, and lastly thin hydrocolloid to block the reaction from the hollister barrier. This seems to have worked. The patient has been switched to a different brand of urostomy pouches with some success. Symptoms included rash, urticaria, and pruritus.
 
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Brand NamePREMIER CONVEX UROSTOMY POUCH WITH PRE-SIZED BARRIER
Type of DevicePREMIER CONVEX UROSTOMY POUCH WITH PRE-SIZED 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 Key12699118
MDR Text Key278411893
Report Number1119193-2021-00035
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number8483
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2021
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: 10/26/2021 Patient Sequence Number: 1
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