MAUDE Adverse Event Report: HOLLISTER INCORPORATED MODERMA FLEX CONVEX CERAPLUS TAPE BORDERED CUT TO FIT POUCH

Catalog Number 54600

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

This product sku, 54600, is not sold in the us but is equivalent to 8918, premier one-piece drainable ostomy pouch which is sold in the us.End user's exact weight not known so an estimate was used.Lot number and sample not available so a dhr review and sample evaluation is not possible.Trend analysis was conducted for tape causing skin irritation for both 54600 and 8918 and no adverse trends observed.The root cause of the end user's skin reaction to the tape 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.There were no issues at the beginning but developed sensitivities after a few weeks.The skin was red and irritated.She was prescribed a steroid ointment for her skin.She is now using a different ostomy appliance without any reported issues.

• Brand Name: MODERMA FLEX CONVEX CERAPLUS TAPE BORDERED CUT TO FIT POUCH
• Type of Device: MODERMA FLEX CONVEX CERAPLUS TAPE BORDERED CUT TO FIT 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: 11399349
• MDR Text Key: 234419974
• Report Number: 9616668-2021-00004
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 54600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2021
• 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: 68 YR
• Patient Weight: 82