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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED MODERMA FLEX SOFT CONVEX CERAPLUS UROSTOMY POUCH

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HOLLISTER INCORPORATED MODERMA FLEX SOFT CONVEX CERAPLUS UROSTOMY POUCH Back to Search Results
Catalog Number 59901
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Infection (4544)
Event Date 11/18/2020
Event Type  Injury  
Manufacturer Narrative
Device history record review conducted on sku and lot number provided and the records were found to be complete and accurate. This product is provided non-sterile. End user's age not provided so estimate used. Since reported skin infections have occurred periodically over several years and over several product types and manufacturers, this is not sku or lot specific. Hollister will continue to monitor the performance of this product in the market.
 
Event Description
The end user reported red, itchy skin under hollister barrier for his urostomy stoma. He went to his healthcare provider who collected a swab from the affected skin and determined that it was an infection. He was prescribed antibiotics and the area is beginning to clear up. The end user has been experiencing skin infections on and off for several years with different types and brands of stoma barriers.
 
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Brand NameMODERMA FLEX SOFT CONVEX CERAPLUS UROSTOMY POUCH
Type of DeviceMODERMA FLEX SOFT CONVEX CERAPLUS UROSTOMY POUCH
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister drive
libertyville IL 60048 3781
Manufacturer (Section G)
HOLLISTER ULC
foxford rd.
rehins
ballina, county mayo
EI
Manufacturer Contact
linda wisowaty
2000 hollister drive
libertyville. 60048-3781
8476802170
MDR Report Key11012592
MDR Text Key221726251
Report Number9616668-2020-00006
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,study
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number59901
Device Lot Number0K052
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/15/2020 Patient Sequence Number: 1
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