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

Lot Number 7062708

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

Event Type  malfunction  

Event Description

Patients husband reported that he received 8-9 defective rolls of hy-tape (stated lot# 7062708).Husband states that it appears that the rolls were not wrapped correctly that half of the tape was not aligned with the rest so part of the tape is exposed and not sanitary; that they were rolled up crooked.Husband states that he will still use them since fortunately not being placed on open site/skin.Patient did not miss dose.Patient did not experience adverse event.Unknown if patient has product on hand for return.Replacing with two new rolls per husband request.No further information provided.No side effects reported.Event dates are unknown as not reported.#110blf.Reported to (b)(6) by: patient/caregiver.Reference reports: mw5149923, mw5149924, mw5149925, mw5149926, mw5149927, mw5149928, mw5149929.

• Brand Name: TAPE HY-TAPE 1"X5YD
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): HY-TAPE INTERNATIONAL, INC.
• MDR Report Key: 18474583
• MDR Text Key: 332672644
• Report Number: MW5149930
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• 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: 01/04/2024

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
• Device Lot Number: 7062708
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Patient Sequence Number: 1
• Treatment: AMBRISENTAN.; C-FORMULATION D W/CLONI 0.2%. ; C-TREPROSTINIL (3ML)RM.
• Patient Sex: Female