TEN20 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-08 for TEN20 * manufactured by D.o. Weaver And Company.

Event Text Entries

[4845600] Pt had eeg previous day. Nuprep and ten20 were used during the eeg. Order for eeg leads to be removed today. Post removal of leads, two pink teardrop areas noted to forehead. Approximately one hour later, the areas seemed larger and pinker, especially on the right side which appeared edematous and slightly abraded to center. The area continued to get slightly larger and puffier over the next hour. Mds alerted and skin team consulted.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4023147
• MDR Report Key: 4023147
• Date Received: 2014-04-08
• Date of Report: 2014-04-08
• Date of Event: 2014-03-23
• Report Date: 2014-04-08
• Date Reported to FDA: 2014-04-08
• Date Reported to Mfgr: 2014-08-20
• Date Added to Maude: 2014-08-20
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TEN20
• Generic Name: MEDIA, ELECTROCONDUCTIVE
• Product Code: GYB
• Date Received: 2014-04-08
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 0 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: D.O. WEAVER AND COMPANY
• Manufacturer Address: 565 NUCLA WAY, AURORA CO * US *

Device Sequence Number: 2

• Brand Name: NUPREP
• Generic Name: ELECTRODE, ELECTROCARDIOGRAPH
• Product Code: GYB
• Date Received: 2014-04-08
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 0 YR
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: D.O. WEAVER AND COMPANY
• Manufacturer Address: 565 NUCLA WAY, AURORA CO 80011 US 80011

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-04-08