MAUDE Adverse Event Report: HOLLISTER INCORPORATED MODERMA FLEX SOFT CONVEX CERAPLUS 25 MM PRE-SIZED BARRIER

Catalog Number 59825

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

Patient Problem Skin Irritation (2076)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Trend data reviewed and no adverse trends identified.Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Dhr review completed and no issues identified.Sample review not possible because no sample available.End user's weight not known so estimation used.Product 59825 is not sold in the united states but the similar product, 8414 is sold in the us so this medwatch because of that similar product sold in the us.The root cause of the peristomal skin rash cannot be determined.

Event Description

It was reported that an end user developed a bad rash under the hollister ostomy barrier.The end user saw his health care professional and was prescribed oral antibiotics.The rash has since cleared up and he is using a different ostomy barrier product.

• Brand Name: MODERMA FLEX SOFT CONVEX CERAPLUS 25 MM PRE-SIZED BARRIER
• Type of Device: MODERMA FLEX SOFT CONVEX CERAPLUS 25 MM PRE-SIZED BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville, il
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, county mayo ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., ; 6802170
• MDR Report Key: 10333345
• MDR Text Key: 207335005
• Report Number: 1119193-2020-00019
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2020

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: 59825
• Device Lot Number: 0D223
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/28/2020
• 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: 66 YR
• Patient Weight: 82