MAUDE Adverse Event Report: MCKESSON MEDI-TAK

Device Problem Occlusion Within Device (1423)

Patient Problem Hyperglycemia (1905)

Event Date 07/23/2015

Event Type  Injury  

Event Description

While at (b)(6) cancer center for treatment, a medi-tak patch was utilized to warm patient's vein to make it more accessible for an iv.A 3rd degree burn was noticed at site.Currently nurses are changing bandages daily and a referral to a plastic surgeon has been made.

• Brand Name: MEDI-TAK
• Type of Device: MEDI-TAK
• Manufacturer (Section D): MCKESSON
• MDR Report Key: 4992662
• MDR Text Key: 22596218
• Report Number: MW5055251
• Device Sequence Number: 1
• Product Code: IMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 08/11/2015

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?: Yes
• Device Operator: No Information
• Other Device ID Number: 16-9706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR