MAUDE Adverse Event Report: DYNAREX CORP. PAPER SURGICAL TAPE; TAPE AND BANDAGE, ADHESIVE

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/27/2023

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) 2023.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PAPER SURGICAL TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): DYNAREX CORP.
• MDR Report Key: 18768591
• MDR Text Key: 336233094
• Report Number: MW5151880
• 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: Other
• Type of Report: Initial
• Report Date: 02/20/2024

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: 02/22/2024
• Patient Sequence Number: 1