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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Type  Injury  

Event Description

Patient stated she cannot wait to get the device removed because the tape itches so bad.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Refer to addition documents in 12k.

• Brand Name: TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 17279129
• MDR Text Key: 318612820
• Report Number: MW5119172
• 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: 07/05/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Patient Sequence Number: 1