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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 84798
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Erosion (2075); Tissue Breakdown (2681)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative
Trend analysis conducted and no adverse trends observed for skin irritation or pressure injury. 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 peristomal wounds cannot be determined.
 
Event Description
It was reported that on (b)(6) 2021 an end user with a urostomy started experiencing peristomal wounds under the hollister premier convex barrier at about the same time he started using the new hope hernia belt with his hollister appliance. The end user reported that he needed to use a convex barrier and the hernia belt in order to prevent urine leakage due to multiple abdominal hernias. The end user reported that he is now seeing a wocn regularly who is using a cautery stick to cauterize areas of the wound that are bleeding and is using silver alginate wound dressings on the peristomal wounds. The end user reported that he does not believe the hollister appliance is malfunctioning or that this is related to any particular lot of appliance. Hollister is sending other ostomy products for him 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 Key14085935
MDR Text Key289089848
Report Number1119193-2022-00009
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 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number84798
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/07/2022
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: 04/12/2022 Patient Sequence Number: 1
Treatment
NEW HOPE 8" HERNIA BELT
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