MAUDE Adverse Event Report: UNKNOWN SURGICAL TAPE; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Swelling (2091); Burning Sensation (2146); Caustic/Chemical Burns (2549)

Event Date 07/16/2020

Event Type  Injury  

Event Description

Caused chemical burn.Medical/ surgical tape was used to affix gauze to the right eye to form an eye patch on (b)(6) 2020.It was to stay on until (b)(6) 2020.On the morning of (b)(6) 2020 the skin around the eye, under the tape felt like it "was burning''.On removing the tape, raised welts were discovered from a chemical burn caused by the tape.The area looked like someone had held a hot iron the face.No test was done but a return to the eye doctor was required that day.Fda safety report id #: (b)(4).

• Brand Name: SURGICAL TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10307894
• MDR Text Key: 200213588
• Report Number: MW5095665
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 90