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

Model Number FSVM01/10

Device Problem Insufficient Information (3190)

Patient Problem Skin Tears (2516)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

As neither a lot number nor samples have been made available to us, no analyses could be performed so far.We have requested further information on the patient, the skin preparation, if and how the skin injury had to be treated and will provide a follow up report upon receipt.

Event Description

On (b)(6) 2020, we have been informed about an incident with ecg electrodes at (b)(4) ambulance servicel, (b)(4).Xlbleu electrodes model fs-wa01c+/10 were used.The complainant reported " an incident occured whilst removal of a ecg electrode.The crew were very carefully removing the electrode as the patient had frail delicate skin, however it still caused a skin tear.I have read the instructions printed on the back of the packet and i can assure you these instructions were followed.Have you any other suggestions of how we can avoid this in the future please".We have requested further information on the patient, the skin preparation, if and how the skin injury had to be treated.

Manufacturer Narrative

As neither a lot number nor samples have been made available to us, no analyses could be performed so far.We assume based on the information provided in the questionnaire that the patient condition (dry and brittle skin) might have caused or contributed to the incident.It was further disclosed by the reporter of the incident that the injury did not have to be treated.No further conclusion can be drawn.We therefore close the investigation.

Event Description

On (b)(6) 2020, we have been informed about an incident with ecg electrodes at east midlands ambulance servicel, nhs trust, in uk.Xlbleu electrodes model fs-wa01c+/10 were used.The complainant reported "(.) an incident occurred whilst removal of a ecg electrode.The crew were very carefully removing the electrode as the patient had frail delicate skin, however it still caused a skin tear.I have read the instructions printed on the back of the packet and i can assure you these instructions were followed.Have you any other suggestions of how we can avoid this in the future please".We have requested further information and received on (b)(6) 2020 a filled in questionnaire.A 5 minutes 12 lead ecg "monitoring / assessment" was performed.A lifepak 15 was used as ecg machine.The patient was described as slim and the general status of the patient was described as normal.The skin type was described as dry and brittle.The skin was not cleaned, not shaven, not disinfection before applying the ecg electrodes.10 electrodes were applied in total to the patient.It was reported that the ecg electrodes adhered well to the patient skin.During removal of one of the ecg electrode a skin tear (minimal bleeding) was detected underneath the adhesive of the ecg electrode the size of a 10p coin.A photo of the injury was provided.On the photo a skin tear is visible on a forearm of an elderly patient with a fragile skin.It was also reported that no treatment of the injury was necessary.

• Brand Name: XLBLEU
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 10216795
• MDR Text Key: 197572033
• Report Number: 8020045-2020-00014
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531001453
• UDI-Public: (01)19005531001453
• Combination Product (y/n): N
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

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: FSVM01/10
• Device Catalogue Number: FS-WA01C+/10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 91 YR