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

Model Number	W-601
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Retained samples of the same lot have been inspected visually and electrically.Mechanical tests were performed on 4 retained samples.All tested samples were found to perform within limits.No faults could be detected.No conclusion regarding the cause of the skin injury can be drawn.No information on skin type, state of skin and whether any medication was being taken, which might have a skin weakening effect, was provided.The initial reporter communicated no further information will be provided.We therefore close this complaint.
Event or Problem Description
On (b)(6) 2018, we have been informed about an incident with ecg electrodes.Monitoring ecg electrodes (model sbw601) and an unknown heart monitoring recorder had been used.The initial report "(b)(6) 2018 incoming patient stated that they are mailing the device back right now due to the electrodes- they haven't used the monitor the last two days their skin was oozing and had opened sores.They only had the monitor on for only 2 to 3 days and when they took the electrodes off it ripped their skin (.)." no further information was provided if and how the injury had to been treated as the reporter stated it was all the information he could provide.

• Brand Name: STABLE BASE
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 8154235
• Report Number: 8020045-2018-00025
• Device Sequence Number: 2165919
• Product Code: DRX
• UDI-Device Identifier: 10861779000274
• UDI-Public: (01)10861779000274
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K023503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: W-601
• Device Catalogue Number: SBW601
• Device Lot Number: 180312-0256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other