MAUDE Adverse Event Report: Hollister Incoporated InView Standard; Male Incontinence Catheter, Self-Adhesive

Catalog Number	97532
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adhesive Too Strong (4071)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/25/2026
Type of Reportable Event	Other

• Brand Name: InView Standard
• Common Device Name: Male Incontinence Catheter, Self-Adhesive
• Manufacturer (Section D): Hollister Incoporated; 2000 hollister drive; libertyville IL 60048
• Manufacturer (Section G): EuroMed; 25 corporate drive; orangeburg NY 10962
• Manufacturer Contact: andrea clark ; 2000 hollister drive; libertyville, IL 60048 ; +1(463)266-7911
• MDR Report Key: 50873299
• Report Number: 1480288-2026-00004
• Device Sequence Number: 10715258
• Product Code: NNX
• UDI-Device Identifier: 20610075975321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Lay User/Patient
• Device Catalogue Number: 97532
• Device Lot Number: JUKW1848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown