MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT OSTOMY PASTE; CEMENT, STOMAL APPLIANCE, OSTOMY

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Caller stated in the last two years comfort medical supply company has been tampering with her products before mailing it to her.The labels, lot and reference numbers for this products switched around and some are opened from the original packaging and dumped in the box.Ref reports: mw5152316, mw5152317, mw5152319, mw5152320, mw5152321.

• Brand Name: ADAPT OSTOMY PASTE
• Type of Device: CEMENT, STOMAL APPLIANCE, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 18845031
• MDR Text Key: 337082525
• Report Number: MW5152318
• Device Sequence Number: 1
• Product Code: EZR
• 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

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White