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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient's husband had specific complaint about the hytape he has received for past couple of shipments getting the end cap of tape.(half width of role is off the core of tape) does not have lot number.Expiration date unknown.Unknown if patient missed dose or experienced an adverse event.Unknown if patient has product on hand.Tape used for subcutaneous remodulin/remunity pharmacy fill.No additional information available.Reported to cvs/caremark by: patient/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: 18419289
• MDR Text Key: 331713280
• Report Number: MW5149677
• 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: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Patient Sequence Number: 1
• Treatment: C-TREPRDSTINIL(2ML)RM.; LIDOCAINE/PRILOCAINE CRM. ; TRIAMCINOLONE ACET CRM.
• Patient Sex: Female