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

Model Number FS-401C

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

As no lot number has been provided, no tests could be performed on retained samples.It is yet unknown whether the skin reaction occurred underneath the electrode's foam tape or underneath it's gel.It is also unclear whether the skin reaction constitutes an injury and whether it had to be treated.It was not possible to receive this information despite repeated requests.We will continue to request further information and will provide any findings in a follow up report.Device not returned to manufacturer.

Event Description

On (b)(6) 2017, we have been informed of an incident during an ecg procedure using dahlhausen ecg electrode (model: 19.000.00.400).The complainant reported "a hospital would like to know what kind of acrylic adhesive the electrode is, a patient reacts allergic to it".No further information on the patient, the lot number of the electrode, and the position of the skin reaction relative to the electrode has been provided despite of repeated requests.

Manufacturer Narrative

As no lot number has been provided, no tests could be performed on retained samples.Our distributor informed us that "the patient just wanted to know the ingredients, as there was a reaction.After the ingredients were disclosed, there was no reply from the end user." it is unknown whether the skin reaction occurred underneath the electrode's foam tape or underneath it's gel.It is also unclear whether the skin reaction constitutes an injury and whether it had to be treated.It was not possible to receive this information despite repeated requests.No root cause on the reaction could be identified.We therefore close the complaint.Device not returned to manufacturer.

Event Description

On (b)(6) 2017, we have been informed of an incident during an ecg procedure using dahlhausen ecg electrode (model: 19.000.00.400).The complainant reported "a hospital would like to know what kind of acrylic adhesive the electrode is, a patient reacts allergic to it".No further information on the patient, the lot number of the electrode, and the position of the skin reaction relative to the electrode has been provided despite of repeated requests.

• Brand Name: DAHLHAUSEN
• 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: 6525222
• MDR Text Key: 73783076
• Report Number: 8020045-2017-00013
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/15/2017

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 Model Number: FS-401C
• Device Catalogue Number: 19.000.00.400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• 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