MAUDE Adverse Event Report: 3M TEGADERM; DRESSING, WOUND, OCCLUSIVE

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943); Swelling (2091); Skin Inflammation (2443)

Event Date 03/24/2017

Event Type  Injury  

Event Description

Tegaderm was used to cover dressings from robotic abdominal surgery.Within 24 hours i had significant contact dermatitis under the areas where the tegaderm was in contact with my skin: large, itchy, fluid-filled blisters - clear at first and then red.I removed the tegaderm as advised by my doctor, but six days later they still itch, though they are crusting over and improving.

• Brand Name: TEGADERM
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): 3M
• MDR Report Key: 6452902
• MDR Text Key: 71632661
• Report Number: MW5068842
• Device Sequence Number: 1
• Product Code: NAD
• 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: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CALCIUM CITRATE; COLACE; OTC MEDS: MULTIVITAMIN; RX MEDS: FOSIMAX; VITAMIN D3
• Patient Age: 61 YR
• Patient Weight: 64