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

Catalog Number 59825

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

This product sku, 59825, is not sold in the us but is equivalent to 8414, premier one-piece urostomy pouch which is sold in the us.A dhr review could not be completed because the lot number was not known.Sample not returned so sample evaluation is not possible.Trend analysis was conducted for tape causing skin irritation for both 59825 and 8414 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 when the end user experienced sore skin under the product she thought her stoma size may have changed.The sore skin extended under the barrier portion as well as an ulcer so she was prescribed a steroid and antibiotic cream.The end user continues to experience red skin but the ulcer has almost fully healed and there is no more pain.It was suggested that she have her ostomy appliance swapped out for an alternative product.

• 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: 11496105
• MDR Text Key: 240604092
• Report Number: 9616668-2021-00007
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 59825
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/16/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 64