MAUDE Adverse Event Report: LEONHARD LANG GMBH FUKUDA DENSHI; ECG ELECTRODE

Model Number F401C

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

As neither a lot number nor samples have been made available to us, no analyses could be performed.We have requested further information because it is unclear how a patient could have swallowed a white round foam ecg electrode with blue print, diameter 40mm.No information has been provided what medical intervention the patient has received and whether any permanent damage has resulted.We will further request for this information and relay any conclusion in a follow up report.

Event Description

On (b)(4) 2022, we have been informed about an incident concerning fukuda denshi ecg monitoring ecg electrodes teo-2020dr (model f401c) from a user in japan.The initial report states: "today, a customer informed us that a patient accidentally swallowed teo-2020dr and asked us for advice.We already answered that the patient have to seek medical attention immediately, the hydrogel can swell up, according to your msds." we have requested further information on the incident itself and the patient but hove received none so far.

Event Description

On december 05th, 2022, we have been informed about an incident concerning fukuda denshi ecg monitoring ecg electrodes teo-2020dr (model f401c) from a user in japan.The initial report states: "today, a customer informed us that a patient accidentally swallowed teo-2020dr and asked us for advice.We already answered that the patient have to seek medical attention immediately, the hydrogel can swell up, according to your msds." we have requested further information on the incident itself and the patient but have received none.

Manufacturer Narrative

As neither a lot number nor samples have been made available to us, no analyses could be performed.We have requested further information because it is unclear how a patient could have swallowed a white round foam ecg electrode with blue print, diameter 40mm.We have repeatedly requested further information on the concerned lot number, the severity of the incident for the patient und if and how the patient had to be treated afterwards.We have been informed that "our distributor says that there are several other distributor between [them and] the hospital so it is difficult to get the detail.We asked him again to contact the customer directly.Here is a few additional information regarding this matter.1.The customer mentioned that if anything happens to the patient, he/she will contact our distributor again.No contact has made after that yet.2.The patient did not get special treatment, just wait and see till the electrode is excreted." as no further information was provided despite repeated requests no conclusion regarding the cause of the incident can be drawn.Anyhow, based on the provided information we assume that no reportable event has happened at all.We therefore close the investigation and the report.

• Brand Name: FUKUDA DENSHI
• 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: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 16031951
• MDR Text Key: 305973526
• Report Number: 8020045-2022-00033
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: F401C
• Device Catalogue Number: TEO-2020DR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2022
• 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
• Patient Race: Asian