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

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.

• Brand Name: MODERMA FLEX SOFT CONVEX CERAPLUS UROSTOMY POUCH
• Type of Device: MODERMA 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 Key: 11012592
• MDR Text Key: 221726251
• Report Number: 9616668-2020-00006
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 59901
• Device Lot Number: 0K052
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 83