MAUDE Adverse Event Report: LEONHARD LANG GMBH XL BLEU; ECG ELECTRODE

Model Number FS-VM01

Device Problem Insufficient Information (3190)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

As neither a lot number nor customer samples have been made available no tests could be performed.After several requests for further investigation we have been informed by the initial reporter that the investigation can be closed as the initial complainant will not provide any further information: "the rep has confirmed they have not filled out the questionnaire, and believes they won't.".Due to lack of information no investigation can be performed and therefore no conclusion regarding the cause of the skin injury can be drawn.We therefore close the investigation.

Event Description

On (b)(6) 2019, we have been informed about incidents with ecg electrodes at a (b)(6) hospital, (b)(6).Electrodes catalog number xl bleu xl-bm01 (our model fs-vm01) were used.No lot number was provided.The complainant reported "we have had a number of patients who have had their skin ripped, no matter how gently we do this, when we remove the ecg dot".We are requesting further information on each involved patient, the skin preparation, the duration of wearing if and how the skin injury had to be treated.

• Brand Name: XL BLEU
• 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, 6020 ; AU 6020
• Manufacturer Contact: burrhus lang ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 9283889
• MDR Text Key: 165214665
• Report Number: 8020045-2019-00024
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531001432
• UDI-Public: (01)19005531001432
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

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-VM01
• Device Catalogue Number: XL-BM01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/06/2019
• 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