MAUDE Adverse Event Report: LEONHARD LANG GMBH STABLE BASE; ECG ELECTRODE

Model Number W-601

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Event Description

On march 09th, 2023, we have been informed an incident with ecg electrodes.Monitoring ecg electrodes (model: sbw601) had been used.The initial report stated "i am trying to find out more information about the electrodes i was supplied with for a 30 day cardiac monitor.I have attached a picture with product information.Do these electrodes contain any latex? i had an allergic reaction and i would like to identify if it is latex (known allergen), adhesive, or something else.The company who provided me with the electrodes could not answer my question." attached to these initial report a photo was provided showing a pouch of stable base ecg electrode lot number: 220715-0153.On march 13rd, 2023 we have received additional information in a filled in questionaire.A monitoring of arrhythmia was performed.The patient skin was described as normal and the general state also as normal.The medical history was described as "psoriasis, eczema, multiple allergies including latex, asthama".5 ecg electrode per use have been placed in the chest / abdomen area.In total the patient used 35 electrodes in 23 days.The patient described that the procedure should last for 30 days but was "shortened due to skin irritation and no available skin to apply electrodes that was intact / no rash.23 days total".The skin spreperation was described as cleaned, not shaven, not disinfected but has been dried and the rash was treated with "vtama, hydrocortisone".The ecg electrode were adhering to the patient skin and residues haves "sometimes - cleaned gently with soap to remove adhesive" "during and after 30 day monitor" in the chest, abdomen area "redness, rash-raised, itching then scabbed areas" have been detected "underneath adhesive and gel areas around edge in middle".The size was described as "1-2 inch areas where electrodes touched skin".The skin injury was treated by topical medications.No further details have been disclosed.

Manufacturer Narrative

Retained samples of the concerned lot/batch of model: sbt601 have been inspected visually.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.The product does not contain any latex, which was communicated to the user.It is conceivable that her preexisting skin issues have contributed or caused the incident.No further analysis can be performed.We therefore consider the investigation and the report closed.

• Brand Name: STABLE BASE
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer Contact: archenweg 56; innsbruck, 6020
• MDR Report Key: 16680267
• MDR Text Key: 312674153
• Report Number: 8020045-2023-00008
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10861779000274
• UDI-Public: (01)10861779000274
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2023

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: W-601
• Device Catalogue Number: SBW601
• Device Lot Number: 220715-0153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 78 KG