MAUDE Adverse Event Report: TECHNOMED EUROPE NEUROGUARD; DISPOSABLE SUBDERMAL NEEDLE ELECTRODE

Model Number	S41-938
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Technomed received a complaint via mpower/cadwell with a reported incident that resulted in a patient burn involving a neuroguard electrode (ref#: s41-938; lot#: 102884).The neuroguard electrode used and the cadwell equipment were owned by (b)(6).Small burn notes at erbs point recording site in left clavicle.
Event or Problem Description
Technomed reveiced a complaint via mpower/cadwell with a reported incident that resulted in a patient burn involving a neuroguard electrode (ref # s41-938; lot # 102884).The neuroguard electrode used and the cadwell equipment were owned by (b)(6).Small burn notes at erbs point recording site in left clavicle.
Additional Manufacturer Narrative
Distributor of the product has been contacted on multiple occasions for more information on this event.No complaint was reported to the distributor and no additional details were received by technomed.Due to insufficient information, the investigation could not be completed and is therefore closed.

• Brand Name: NEUROGUARD
• Common Device Name: DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
• Manufacturer (Section D): TECHNOMED EUROPE; wiebachstraat 25a; kerkrade; kerkrade, limburg 6466 NG; NL 6466 NG
• Manufacturer (Section G): TECHNOMED ASIA; k.i. trikencana kav. 4-5, jl.; kopo katapang km 11; bandung, jawa barat 40921 ; ID 40921
• Manufacturer Contact: isabelle fiandaca ; wiebachstraat 25a; kerkrade; kerkrade, limburg 6466 -NG ; NL 6466 NG
• MDR Report Key: 24935949
• Report Number: 9710376-2026-00003
• Device Sequence Number: 5356963
• Product Code: GXZ
• UDI-Device Identifier: 08718375863213
• UDI-Public: 08718375863213
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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
• Device Model Number: S41-938
• Device Catalogue Number: A000989
• Device Lot Number: 102884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown