MAUDE Adverse Event Report: HOLLISTER INCROPORATED MODERMAFLEX CONVEX UROSTOMY POUCH WITH CUT TO FIT BARRIER

Catalog Number 2979025

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

Patient Problem Rash (2033)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

This hollister sku, 2979025, which is not sold in the us, is equivalent to hollister premier urostomy pouch, sku 84794, which is sold in the us.Since the lot number was not provided, a dhr review is not possible.Sample not returned so sample evaluation is not possible.Patient's age, gender, weight and race not known.The patient is now using a hollister urostomy pouch that does not have a tape border and is not experiencing a skin reaction.

Event Description

It was reported that a patient in a clinic used cortisone to clear up a rash under the tape border of the hollister ostomy barrier.When the patient started using the hollister barrier with a tape border again, the rash returned within 24 hours.The clinician says this is a contact allergy to the adhesive.

• Brand Name: MODERMAFLEX CONVEX UROSTOMY POUCH WITH CUT TO FIT BARRIER
• Type of Device: MODERMAFLEX CONVEX UROSTOMY POUCH WITH CUT TO FIT BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 12699188
• MDR Text Key: 278413162
• Report Number: 1119193-2021-00034
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2021

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: 2979025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/26/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68