MAUDE Adverse Event Report: DRESSING PRIMAPORE 2 'X3''; TAPE AND BANDAGE, ADHESIVE

Device Problems Output Problem (3005); Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Patient reported her skin gets irritated by the adhesive from dressings/aguaguards.She has tried and failed opsite iv-3000, primapore and sorbaview.So far, allevyn is working for her.Patient did not provide any lot/expiration information for any of the dressings.Patient did not advise whether or not any of the dressing are available for investigation though it is unlikely ary are available.No other information known.Reported to (b)(6) by: patient/caregiver.

• Brand Name: DRESSING PRIMAPORE 2 'X3''
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 11893272
• MDR Text Key: 253159335
• Report Number: MW5101571
• Device Sequence Number: 1
• 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: 05/24/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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
• Patient Sequence Number: 1