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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Inflammation (1932); Swelling (2091)

Event Date 03/01/2019

Event Type  Injury  

Event Description

Had outpatient procedure, after discharge, horrible blistering inflamed bright red skin where mastidol adhesive was used.How was it used or taken: topical; frequency: as needed; dates of use: (b)(6) 2019.

• Brand Name: MASTISOL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 8551653
• MDR Text Key: 143259043
• Report Number: MW5086187
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): Y
• 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: 03/06/2019

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: 04/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 52