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

Model Number FSTB.C.A

Device Problem Insufficient Information (3190)

Patient Problems Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

On (b)(6) 2023, we have been informed about 158 complaints with ecg electrodes collected by philips over a period from 2021 till 2023.Monitoring ecg electrodes reference m2202a (our model fstb.C.A) and monitoring ecg electrodes reference (b)(4) (our model f55 ) had been concerned.Reviewing these 158 complaints we had detected that 7 complaints cite a skin injury.5 complaints have been logged by (b)(6) 2021 specyfing a skin injury happened in the us.It was initially stated that "over the past 4-6 months, nss has noted that the electrodes are more difficult to remove even with the use of remove and they had a couple instances of removal of the electrodes caused skin injury." concerned monitoring ecg electrodes reference (b)(4) (our model fstb.C.A) lot number: 200618-0419.1 complaint has been logged by (b)(6) 2022 specyfing a skin injury happened in china.It was initially stated that "the patient was admitted to hospital for "repeated nausea and vomiting for more than 4 hours after taking about 80ml of prorate," the doctor to do ecg monitor.After check the patient, the doctor find the skin of patient are damaged,about 1.5mm × 3.5mm, the doctor replace the electrode pads immediately." concerned monitoring ecg electrodes reference (b)(4) (our model f55 ) lot number: unknwon.1 complaint has been logged by (b)(6) 2022 specyfing a skin injury happened in japan.It was initially stated that "the patient's skin peeled off when using an oval x-ray transparent electrode." concerned monitoring ecg electrodes reference (b)(4) (our model fstb.C.A) lot number: unknown.No further information was provided.It is unclear wheter a medical intervention was necessary to treat the skin injuries preventing a permanent skin damage.

Manufacturer Narrative

The concerned lot number 200618-0419 has already been expired in june 18th, 2022.As also no samples or other further information have been made available to us so far, no analysis could be performed.For the other two incidents no concerned lot number was specified.As neither a lot number, samples or other further information have been made available to us so far, no analysis could be performed.We have requested for further information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, details of the use and if a medical treatment was necessary but none have been received so far.We will provide a follow up report once any will be available.

Event Description

On may 11th, 2023, we have been informed about 158 complaints with ecg electrodes collected by philips over a period from 2021 till 2023.Monitoring ecg electrodes reference (b)(4) (our model fstb.C.A) and monitoring ecg electrodes reference (b)(4) (our model f55 ) had been concerned.Reviewing these 158 complaints we had detected that 7 complaints cite a skin injury.5 complaints have been logged by february 1st, 2021 specyfing a skin injury happened in the us.It was initially stated that "over the past 4-6 months, nss has noted that the electrodes are more difficult to remove even with the use of remove and they had a couple instances of removal of the electrodes caused skin injury." concerned monitoring ecg electrodes reference (b)(4) (our model fstb.C.A) lot number: 200618-0419.1 complaint has been logged by march 2nd, 2022 specyfing a skin injury happened in china.It was initially stated that "the patient was admitted to hospital for "repeated nausea and vomiting for more than 4 hours after taking about 80ml of prorate," the doctor to do ecg monitor.After check the patient, the doctor find the skin of patient are damaged,about 1.5mm × 3.5mm, the doctor replace the electrode pads immediately." concerned monitoring ecg electrodes reference 40493e (our model f55 ) lot number: unknwon.1 complaint has been logged by october 26th, 2022 specyfing a skin injury happened in japan.It was initially stated that "the patient's skin peeled off when using an oval x-ray transparent electrode.".Concerned monitoring ecg electrodes reference m2202a (our model fstb.C.A) lot number: unknown.No further information was provided.It is unclear wheter a medical intervention was necessary to treat the skin injuries preventing a permanent skin damage.

Manufacturer Narrative

The concerned lot number 200618-0419 has already been expired in june 18th, 2022.As also no samples or other further information have been made available to us, no analysis could be performed.For the other two incidents no concerned lot number was specified.As neither a lot number, samples or other further information have been made available to us, no analysis could be performed.We have requested for further information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, details of the use and if a medical treatment was necessary but none have been received so far.On june 15th, 2023 we have been informed that "no further information is available" and that "the reported skin irritations did not require medical follow up.".As no medical treatment was necessary to treat the skin irritations we conclude that these incidents constitute no reportable events anymore.We therefore consider the investigation and the report closed.

• Brand Name: PHILIP
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 17077978
• MDR Text Key: 316847212
• Report Number: 8020045-2023-00017
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 20861779000288
• UDI-Public: (01)20861779000288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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: 06/18/2022
• Device Model Number: FSTB.C.A
• Device Catalogue Number: M2202A
• Device Lot Number: 200618-0419
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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