MAUDE Adverse Event Report: HY-TAPE INTERNATIONAL, INC. TAPE HY-TAPE 1"X5YD; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Itching Sensation (1943); Pain (1994); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

During inbound call for consult on patient's sq treprostinil, patient reported: date of last site change: (b)(6) 2022.Reports site pain and itch at this time as well as irritation.Pt believes it may be the hytape could be causing this.Pt is seeing md in person to discuss next week (wednesday).Pt also reported that she felt it was harder to breathe when she is walking outside now.She has oxygen available for use and has not had to increase her oxygen at this time.She is informing md at her visit next week.No additional information available at this time.Reported to (b)(6) by pt/caregiver.

• Brand Name: TAPE HY-TAPE 1"X5YD
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): HY-TAPE INTERNATIONAL, INC.
• MDR Report Key: 15864819
• MDR Text Key: 304423577
• Report Number: MW5113462
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2022
• Patient Sequence Number: 1
• Patient Sex: Female