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

Model Number W-602

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the same lot number were inspected visually and mechanically.In addition, two electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.The retained samples were within specification.It is unknown whether the skin reactions occurred underneath the electrode's foam tape or underneath it's gel.It is also unclear whether the skin reactions constitutes an injury and whether it had to be treated.It was not possible to receive this information despite repeated requests.We will provide an update in a follow-up report.Device not returned.

Event Description

On (b)(6) 2017, we have been informed by (b)(6), (b)(6), about an incident involving an unknown ecg monitor and skintact w-602 ecg electrodes.The complainant reported "skin irritation from w-602 and the lot number is 170223-0073 ( total (b)(4) patients have problems)".No further information on the patients, the skin preparation, the duration of application and the position of the skin reaction relative to the electrode has been provided.

Manufacturer Narrative

Retained samples of the same lot number were inspected visually and mechanically.In addition, two electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.The retained samples were within specification.It has not been reported in what kind of procedure the electrodes had been used, how the skin was prepped, how quickly the reactions developed and whether the skin reactions formed underneath all or only some electrodes.It is also unknown whether the skin reactions had to be treated and the incident constitutes a reportable event.It was not possible to receive this information despite repeated requests.Our distributor informed us on (b)(6) that their customer is not willing to provide clearer pictures of the injuries or complete the incident related questionnaires he had received from the distributor.Without this information, no further analyses can be conducted.We therefore consider the investigation closed.Device not returned.

Event Description

On (b)(6) 2017, we have been informed by (b)(4), about an incident involving an unknown ecg monitor and skintact w-602 ecg electrodes.The complainant reported "skin irritation from w-602 and the lot number is 170223-0073 ( total 6 patients have problems)".No further information on the patients, the skin preparation, the duration of application and the position of the skin reaction relative to the electrode has been provided.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: burrhus lang ; archenweg 56; 6020 innsbruck; innsbruck, tirol ; AU ; 512 334254
• MDR Report Key: 6816218
• MDR Text Key: 83459109
• Report Number: 8020045-2017-00021
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

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 Expiration Date: 02/23/2020
• Device Model Number: W-602
• Device Lot Number: 170223-0073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other