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

Model Number FSTC1

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

As neither a lot number nor samples have been made available to us, no analyses could be performed.No information how the skin was prepped has been provided.It is also unclear whether "hurt skin" constitutes injuries and whether they had to be treated.It was not possible to receive this information despite repeated requests.Our distributor informed us that "the problem was not from the ecg electrodes.The main problem was from the user(nurse).(.) because this is nothing to do with electrodes therefore we closed the complain by ourselves." it is unclear whether the user has followed the instruction for use.But the ifu explicitly states the warning: "after use, carefully remove the electrode using one hand whilst supporting the skin beneath it with the other.Ripping off the electrode or peeling it off quickly may damage the skin.Exercise particular caution if the skin is exceptionally sensitive, especially with children but also with elderly patients, diabetics, or patients on a prolonged course of certain medications known to cause dermatological side effects." we therefore consider the investigation and the complaint closed.

Event Description

On (b)(6) 2020, we have been informed about an incident with ecg electrodes at an unknown healthcare facility in taiwan.Sofmed electrodes model f-tc1 have been used.The complainant reported "there is a case that the patient was hurt because the foam [is] too sticky." further on we have been informed that the patient had a thin skin and the electrodes were "hard to peel off from skin".No further details have been disclosed despite repeated requests.

• Brand Name: SOFMED
• 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: 11192684
• MDR Text Key: 229310800
• Report Number: 8020045-2021-00003
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531001354
• UDI-Public: (01)19005531001354
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/19/2021

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: FSTC1
• Device Catalogue Number: F-TC1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/19/2021
• 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 Age: 90 YR