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

Catalog Number 59901

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

This product sku, 59901, is not sold in the us but is equivalent to 84138, premier one-piece urostomy pouch which is sold in the us.Dhr review completed and found to be complete and accurate.Sample not returned so sample evaluation is not possible.Trend analysis was conducted for tape causing skin irritation for both 59901 and 84138 and no adverse trends observed.The root cause of the end user's skin reaction to the appliance is not known.

Event Description

It was reported that an end user started experiencing a skin reaction to the tape border of the hollister ostomy barrier.At first the end user experienced an itch under the product but his skin looked okay.The end user was also wearing hernia belt.The itch continued and he developed redness and some leaks.He was prescribed a steroid cream for his skin.The end user continues to experience itchy skin for which he was prescribed zyrtek.He is awaiting samples of an alternative pouch to try.

• Brand Name: MODERMA FLEX SOFT CONVEX CERAPLUS TAPE BORDERED UROSTOMY POUCH
• Type of Device: MODERMA FLEX SOFT CONVEX CERAPLUS TAPE BORDERED UROSTOMY POUCH
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, rehins ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 11496109
• MDR Text Key: 252961055
• Report Number: 9616668-2021-00006
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• 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: 0J123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• Is the Device Single Use?: Yes
• 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: 75 YR
• Patient Weight: 89