MAUDE Adverse Event Report: MEDIPORE; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

Spontaneous call and spoke with patient who reports opsite - iv 300 dressing, hy-tape, and medipore was causing skin to turn red and when removed it would leave skin with cuts and irritated.Patient using hydrocortisone and switched to 3m transpore tape is working well with no irritation, clear patch is tegaderm 3mm and is much smoother and no wrinkle or irritation.Just skin irritation with dressing and tape reported, no side effects with remodulin, opsumit, or adempas (uptravi was already discontinued).Reported to (b)(6) by: patient/caregiver.

• Brand Name: MEDIPORE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 11372652
• MDR Text Key: 233738422
• Report Number: MW5099603
• Device Sequence Number: 2
• Product Code: KGX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2021
• Patient Sequence Number: 1