MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT LUBRICATING DEODORANT; OSTOMY CARE KIT

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Product and packaging has been tampered with.Ref reports: mw5152316, mw5152317, mw5152318, mw5152319, and mw5152320.

• Brand Name: ADAPT LUBRICATING DEODORANT
• Type of Device: OSTOMY CARE KIT
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 18845053
• MDR Text Key: 337088580
• Report Number: MW5152321
• Device Sequence Number: 1
• Product Code: PQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White