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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER FLEXTEND UROSTOMY POUCH WITH CUT TO FIT BARRIER

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HOLLISTER INCROPORATED PREMIER FLEXTEND UROSTOMY POUCH WITH CUT TO FIT BARRIER Back to Search Results
Catalog Number 8460
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033); Skin Erosion (2075); Urticaria (2278); Blister (4537)
Event Date 06/30/2021
Event Type  Injury  
Manufacturer Narrative
Sku/part number not provided so representative sku assigned to this report. Since sku number not provided, trend analysis could not be conducted. 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. The treatment and outcome of any treatment is not known. Account not able to provide any further information or event details so hollister is unable to conduct an investigation or determine a root cause.
 
Event Description
It was reported that a patient who was using hollister's premier urostomy pouching system was found to have a moderate reaction with red open weeping rash and formation of large open peristomal wound. Symptoms included skin rash, urticaria, pruritus and blisters.
 
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Brand NamePREMIER FLEXTEND UROSTOMY POUCH WITH CUT TO FIT BARRIER
Type of DevicePREMIER FLEXTEND UROSTOMY POUCH WITH CUT TO FIT 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 Key12699122
MDR Text Key278408891
Report Number1119193-2021-00033
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 Number8460
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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