MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; ECG ELECTRODE

Model Number FS-RG1

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

As neither a lot number nor involved samples have been made available to the date of this report no investigation could be performed so far.The incident is reported because it is unknown whether a patient injury has happened at all.The incident might not constitute a reportable event.However we will repeat requesting further information and will relay any in a follow up report.

Event Description

On (b)(6), 2023, we have been informed about an incident with ecg electrodes in allergology in a public hospital ospedale san giovanni di dio, in florence, italy.Skintact electrodes model fs-rg1/10 were used.The initial reporter was requiring "one patient showed suspicious allergic dermatitis after using your electrocardiogram electrodes fs-rg1/10.Therefore i ask you about the chemicals that constitute each part of the electrodes (e.G.The foam, the glue.)." no further details have been disclosed despite repeated requests.

Event Description

On january 31st, 2023, we have been informed about an incident with ecg electrodes in allergology in a public hospital ospedale san giovanni di dio, in florence, italy.Skintact electrodes model fs-rg1/10 were used.The initial reporter was requiring "one patient showed suspicious allergic dermatitis after using your electrocardiogram electrodes fs-rg1/10.Therefore i ask you about the chemicals that constitute each part of the electrodes (e.G.The foam, the glue.)." no further details have been disclosed despite repeated requests.

Manufacturer Narrative

As neither a lot number nor involved samples have been made available to the date of this report no investigation could be performed so far.We have repeatedly requested for further information and have been informed that [translated from german to english]: "the patient is fine.Luckily, the reaction that happens with every application resolves with topical cortisone without any serious injury." further on we have been informed that "the lot number is not available! she [patient] has done many ecgs (the lot number of the electrodes was never written on the ecg report) and now she uses suction cup sensors for ecg." as no further information on the patient and the concerned lot number is available we consider the investigation and the report closed.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 16451138
• MDR Text Key: 310325082
• Report Number: 8020045-2023-00003
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 29005531505753
• UDI-Public: (01)29005531505753
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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 Operator: Health Professional
• Device Model Number: FS-RG1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female