MAUDE Adverse Event Report: TAPE; DRESSING, WOUND, OCCLUSIVE

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

Patient Problem Itching Sensation (1943)

Event Type  Injury  

Event Description

The patient reported she had been really itchy from the tape and gauze and had gone to the doctor for this.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TAPE
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• MDR Report Key: 17298144
• MDR Text Key: 318779027
• Report Number: MW5119251
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/07/2023

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: 07/10/2023
• Patient Sequence Number: 1