MAUDE Adverse Event Report: HOLLISTER GENERIC HOLLISTER ADAPT OSTOMY PASTE

Device Problems Inadequate Instructions for Healthcare Professional (1319); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

Here are two products (hollister adapt ostomy paste and ilex skin protectant paste) that i see mixed up in my practice.The results can lead to major skin breakdown.Medication administered to or used by the pt: no.(b)(6).

• Brand Name: GENERIC HOLLISTER ADAPT OSTOMY PASTE
• Type of Device: GENERIC HOLLISTER ADAPT OSTOMY PASTE
• Manufacturer (Section D): HOLLISTER
• MDR Report Key: 4895224
• MDR Text Key: 18028231
• Report Number: MW5043603
• Device Sequence Number: 1
• Product Code: EXE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1