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

Catalog Number 54300

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/27/2020

Event Type  Injury  

Manufacturer Narrative

This product sku, 54300, is not sold in the us but is equivalent to 8901, 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 & barrier causing skin irritation for both 54300 and 8901 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 a hospital inpatient started experiencing a skin reaction to the hollister ostomy appliance after a few days of use.The skin under the barrier and tape portion was red and irritated.She was prescribed a steroid inhaler to treat the skin irritation.The skin has fully healed with the use of the inhaler and a change of ostomy appliance.

• Brand Name: MODERMA FLEX CERAPLUS TAPE BORDERED CUT TO FIT POUCH
• Type of Device: MODERMA FLEX 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: 11399321
• MDR Text Key: 234300907
• Report Number: 9616668-2021-00005
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 54300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/02/2021
• 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: 55 YR
• Patient Weight: 61