MAUDE Adverse Event Report: HOLLISTER INCROPORATED INVIEW MEC STANDARD 41 MM XL; INVIEW SHEATH STANDARD 41MM XL

Catalog Number	97241
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Contact Dermatitis (4546)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Post market complaint data reviewed and no adverse trend was observed.The root cause of the report of the product not sticking is not known.This sku is not sold in the united states but a similar sku, 97541 - inview standard it sold here.Udi information - the di information is known but the pi information cannot be provided since the exact lot number is not known.
Event or Problem Description
It was reported that for the last 6 weeks the end user's wife said the hollister inview male external catheter felt like different material.It was reported that they were not flat but were fluted and were not sticking at all.It was further reported that caused leakage of urine which burned the skin.Additionally, it was reported that they sought medical help, that the nurse prescribed steroid cream and will continue to monitor the end user regularly.

• Brand Name: INVIEW MEC STANDARD 41 MM XL
• Common Device Name: INVIEW SHEATH STANDARD 41MM XL
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): BD / BARD, INC; av gral roberto fierro; 32685 cd; juarez, chihuahua ; MX
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL
• MDR Report Key: 21292367
• Report Number: 1480288-2025-00002
• Device Sequence Number: 7871548
• Product Code: NNX
• UDI-Device Identifier: 00610075975419
• UDI-Public: 00610075975419
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 97241
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male