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

Catalog Number FS-RE /6

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 04/07/2018

Event Type  Injury  

Event Description

On july 27th, 2022, we have been informed about an incident with ecg electrodes at wythenshawe hospital, in uk.Skintact electrodes model fs-re /6 were used.The complainant reported "this patient was admitted to ctccu on (b)(6) 2018 [sic!] and developed a rash on the left side of the chest later on this area got worsened, infected and necrotic.Patient was very unwell and on ecmo.Plastics team and dermatology were involved, and this left with a scar.Looking through the documentation it was found that this was due to ecg electrode as he had similar one appeared under the ecg dot on his chest." we have requested further information on the involved lot number.

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 additional information on the reported incident.If any will get available we will provide a follow up report.

Manufacturer Narrative

As neither a lot number nor samples have been made available to us, no analysis could be performed so far.We have requested additional information on the concerned lot number and have been informed that "unfortunately i wouldn't keep details of the lot number, as my team only keep track of lot numbers on implants, consignment stock and such items not general items as this is." based on the statement that "this particular patient was very sick and on several medications, very oedematous and there were times we were unable to reposition the patient.So i assume the ecg electrodes might stayed more than what it could be and that caused redness and allergy".We therefore assume that user error contributed or caused the event.The ifu states: "do not use the electrodes longer than the time indicated on the packaging pouch!" the pouch print of the concerned products specifies "do not use for more than 72 hours." we therefore consider the investigation closed.

Event Description

On july 27th, 2022, we have been informed about an incident with ecg electrodes at (b)(6) hospital, in uk.Skintact electrodes model fs-re /6 were used.The complainant reported "this patient was admitted to (b)(6) on (b)(6) 2018 [sic!] and developed a rash on the left side of the chest later on this area got worsened, infected and necrotic.Patient was very unwell and on ecmo.Plastics team and dermatology were involved, and this left with a scar.Looking through the documentation it was found that this was due to ecg electrode as he had similar one appeared under the ecg dot on his chest." we have received the information that "i have completed the incident response and sent it to patient and not heard any further issues.On investigation it was found that no other allergic incident reported due to the ecg electrode, how ever this particular patient was very sick and on several medications, very oedematous and there were times we were unable to reposition the patient.So i assume the ecg electrodes might stayed more than what it could be and that caused redness and allergy." no further details have been disclosed despite repeated requests.

• Brand Name: SKINTACT
• 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, tirol 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 15190125
• MDR Text Key: 297498584
• Report Number: 8020045-2022-00028
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531000272
• UDI-Public: (01)19005531000272
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS-RE /6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 09/19/2022
• 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