MAUDE Adverse Event Report: BARRIER HYDROSEAL SHOWER; DRESSING, WOUND, OCCLUSIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Spontaneous call from patient who reported (via spanish interpreter) that the barrier hydroseals have been irritating her skin.She did not report when she starting experiencing this and how it was irritating her skin.Unknown if her doctor is aware.Patient is on intravenous remodulin therapy.No other information provided.No other info provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: BARRIER HYDROSEAL SHOWER
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• MDR Report Key: 15626632
• MDR Text Key: 302053598
• Report Number: MW5112706
• Device Sequence Number: 1
• Product Code: NAD
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female