MAUDE Adverse Event Report: E5250-0 TC PO2 ELECTRODE

Model Number 945-605

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 06/19/2019

Event Type  Injury  

Event Description

According to the complaint, the skin of the patient was slightly burned during transcutaneous oxygen measurement ultimately leaving a blister.

Manufacturer Narrative

From the investigation, the root cause could not be established.

Manufacturer Narrative

By a mistake, in the initial report, date of this report was stated as november 12th, but should have been november 15th.

• Brand Name: E5250-0 TC PO2 ELECTRODE
• Type of Device: E5250-0 TC PO2 ELECTRODE
• MDR Report Key: 9326072
• MDR Text Key: 166934975
• Report Number: 3002807968-2019-00054
• Device Sequence Number: 1
• Product Code: LKD
• UDI-Device Identifier: 05700699456052
• UDI-Public: 05700699456052
• Combination Product (y/n): N
• PMA/PMN Number: K001866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 945-605
• Device Catalogue Number: 945-605
• Device Lot Number: YW05
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other