MAUDE Adverse Event Report: LEONHARD LANG GMBH XL BLEU; ECG ELECTRODE

Model Number FS-VM01

Device Problem Insufficient Information (3190)

Patient Problems Skin Irritation (2076); Skin Inflammation (2443); Superficial (First Degree) Burn (2685)

Event Date 08/03/2019

Event Type  Injury  

Manufacturer Narrative

Retained samples have been inspected visually and tested mechanically.Mechanical tests were performed on 4 retained samples of the claimed lot number.All tested samples were found to perform within limits.No faults could be detected.No conclusion regarding the cause of the allergic reaction can be drawn so far.We have requested further information and will provide a follow up report upon receipt.

Event Description

On (b)(6) 2019, we have been informed about an incident with ecg electrodes at an ambulance who drove to (b)(6) hospital.Monitoring ecg electrodes model xlbleu fs-wao1c+ have been used.The patient was "rushed to hospital with an svt (supra ventricular tachycardia)".We have received a partially filled in questionnaire.The patient was described as not obese nor fat of body type.The skin type was described as dry skin.The medical history of the patient was described as "previous allergic reactions.Diagnosis - idiopathic allergies include latex, nickel, detergents, plants".The skin preparation was described as: "no cleaning of skin, not shaven, no disinfection, no ointment used.Skin not specifically dried before applying electrodes." the "electrodes were attached properly.There were no skin lesions before attaching electrodes." the duration of monitoring lasted for about 2 hours.The patient reported that the incident "occurred after they [ecg electrodes] were applied." it "occurred as i entered ambulance.Hands started to itch, then arms and body and later eyes starting to itch.Blisters and very itchy.No blockage of airways.Redness left when electrodes were removed some hours later.(.) there were no residues of gel (after 4-6 hours - 2 electrodes were accidentally left in place.I found them when i got home from hospital - redness when i took them off) not sure where all electrodes were placed." the patient was treated by "intravenous meds for svt (adenosine) and allergy." the patient also provided 2 photos showing the chest area with reddish skin reactions after wearing the ecg electrodes.

Event Description

On (b)(6)2019 , we have been informed about an incident with ecg electrodes at an ambulance who drove to queen alexandra hospital.Monitoring ecg electrodes model xlbleu fs-wao1c+ have been used.The patient was "rushed to hospital with an svt (supra ventricular tachycardia)".We have received a partially filled in questionnaire.The patient was described as not obese nor fat of body type.The skin type was described as dry skin.The medical history of the patient was described as "previous allergic reactions.Diagnosis - idiopathic allergies include latex, nickel, detergents, plants".The skin preperation was described as: "no cleaning of skin, not shaven, no disinfection, no ointment used.Skin not specifically dried before applying electrodes." the "electrodes were attached properly.There were no skin lesions before attaching electrodes." the duration of monitoring lasted for about 2 hours.The patient reported that the incident "occurred after they [ecg electrodes] were applied." it "occurred as i entered ambulance.Hands started to itch, then arms and body and later eyes starting to itch.Blisters and very itchy.No blockage of airways.Redness left when electrodes were removed some hours later.(.) there were no residues of gel (after 4-6 hours - 2 electrodes were accidentally left in place.I found them when i got home from hospital - redness when i took them off) not sure where all electrodes were placed." the patient was treated by "intravenous meds for svt (adenisone) and allergy." the patient also provided 2 photos showing the chest area with reddish skin reactions after wearing the ecg electrodes.

Manufacturer Narrative

A photo provided by the patient shows an empty pouch of electrodes and a single used electrode.The two do not correspond (the pouch is for a different model of electrodes).We were only able to further investigate the electrode corresponding to the pouch as only there a lot number is indicated.Retained samples of the same lot (pouch; see above) have been inspected visually and tested mechanically.Mechanical tests were performed on 4 retained samples of the claimed lot number.All tested samples were found to perform within limits.No faults could be detected.Requesting further information at the patient we have been informed that "it is quite possible this has nothing to do with the electrodes.There is written evidence of a possible correlation between svt and an allergic reaction.The heart rate rose, the electrodes were applied, then the allergy appeared half an hour or so later.This might be pure coincidence.There didn't appear to be any sign of it when the paramedics attached the electrodes as it was done in a rush during the emergency before going to hospital - queen alexandra hospital portsmouth, hampshire.I have had electrodes attached before, in hospital, without any adverse reaction." after requesting additional information to further investigate the patients problems the patient stated: "i don't know which ones they used.Maybe they just ditched their empty pouch in my waste bin.So that doesn't really help you.You would have to ask the ambulance provider - whose name i didn't take down in detail.Whatever they are called in the portsmouth area.I shouldn't go to too much trouble.".No conclusion regarding the cause of the allergic reaction can be drawn and we will close the investigation.

• Brand Name: XL BLEU
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 8891932
• MDR Text Key: 154706902
• Report Number: 8020045-2019-00020
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531001456
• UDI-Public: (01)19005531001456
• Combination Product (y/n): N
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

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: 05/29/2021
• Device Model Number: FS-VM01
• Device Catalogue Number: FS-WA01C+
• Device Lot Number: 190529-0209
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 66