MAUDE Adverse Event Report: EIKON DEVICE INC. DYNAREX TAPE; TAPE AND BANDAGE, ADHESIVE

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/29/2024

Event Type  Injury  

Event Description

It was reported to fresenius medical care that the tape (paper surgical tape, dynarex) was not sticking and a needle dislodge during treatment on (b)(6) 2024.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

Event Description

Additional information received on 25-mar-2024, for mw5151836.Correcting manufacturer information.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DYNAREX TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): EIKON DEVICE INC.
• MDR Report Key: 18760127
• MDR Text Key: 336119869
• Report Number: MW5151836
• 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: Unknown
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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: 02/21/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2024
• Patient Sequence Number: 1