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

Model Number FS501

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

As neither customer samples nor the involved lot number were provided for this incident, no tests could be performed.Despite of repeated requests from us, the initial reporter was not able to supply us with more information on the involved product and on the treatment of the injury afterwards.No conclusion regarding the cause of the allergic reaction can be drawn.We will provide a follow up report when we will recieve additional information.

Event Description

On (b)(6) 2021, we have been informed about an incident with ecg electrodes at an ambulance in (b)(6).Monitoring ecg electrodes model medida fs501 have been used.We have been informed by the initial report that "as an emergency patient i received the electrodes mentioned above, now i have a strong allergic reaction".The patient also reported that "i still have red circles that itch after a week." no further information about the patient, the nature and duration of the procedure, how the skin was prepared and if and how the allergic reaction was treated have been disclosed to us despite of repeated requests.

Event Description

On (b)(6) 2021, we have been informed about an incident with ecg electrodes in an ambulance in germany.Monitoring ecg electrodes model medida fs501 have been used.We have been informed by the initial report that "as an emergency patient i received the electrodes mentioned above, now i have a strong allergic reaction".The patient also reported that "i still have red circles that itch after a week." no further information about the patient, the nature and duration of the procedure, how the skin was prepared and if and how the allergic reaction was treated have been disclosed to us despite of repeated requests.

Manufacturer Narrative

As neither customer samples nor the involved lot number were provided for this incident, no tests could be performed.Despite of repeated requests from us, the initial reporter was not able to supply us with more information on the involved product and on the treatment of the injury afterwards.We have been informed on (b)(6) 2021 that: "the allergic reaction was gone about 1 week after.Today [the patient] is fine again." as no further information was provided despite repeated requests no conclusion regarding the cause of the allergic reaction can be drawn.We therefore close the complaint.

• Brand Name: MEDIDIA
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 11192703
• MDR Text Key: 227484191
• Report Number: 8020045-2021-00004
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FS501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other