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

Model Number F-601

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

On (b)(6) 2015, we have been informed about an incident with ecg electrodes.Short term diagnostic electrodes model medirex mf50sg were used.No lot number was provided.The complainant reported "we rec'd an e-mail from a pt who had ecg monitoring with mf50sg electrodes.She might be allergic to some substance of the glue because she had red spots on her body." no further info was provided despite of repeated requests.

Manufacturer Narrative

As no lot number was provided, no tests could be performed on retained samples.Due to the lack of info, we were unable to establish, if these red spots constitute a reportable injury.We will try to obtain add'l info and will provide a f/u report, when we receive it.

• Brand Name: MEDIREX
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck 6020 ; AU 6020
• Manufacturer Contact: burrhus lang ; archenweg 56; innsbruck 6020 ; AU 6020 ; 12334257
• MDR Report Key: 4843705
• MDR Text Key: 16882312
• Report Number: 8020045-2015-00047
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2015

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: F-601
• Device Catalogue Number: MF50SG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 06/12/2015
• 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