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

Model Number T-VO01

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

As neither a lot number nor involved samples have been made available to the date of this report no investigation could be performed so far.The incident is reported because it is unknown whether a patient injury has happened at all or whether this was a proactive inquiry from a user before a product was used.The incident might not constitute a reportable event.However we will repeat requesting further information and will relay any in a follow up report.

Event Description

On october 18th, 2021, we have been informed about an incident with ecg electrodes at (b)(6) skintact electrodes model t-vo01 were used.The initial reporter was requiring "please could you inform me whether the above electrode contains nickel or latex, we have a patient who is highly allergic." no further details have been disclosed despite repeated requests.

Manufacturer Narrative

As neither a lot number nor involved samples have been made available to the date of this report no investigation could be performed so far.We have been informed that no treatment of the allergic reaction was necessary we therefore conclude that no reportable event exist anymore.As no further information was made available despite of repeated requests, no conclusion can be drawn what might have caused the incident as our egc elecrtodes are free of nickel and latex.We therefore close the investigation.

Event Description

On (b)(6) 2021, we have been informed about an incident with ecg electrodes at (b)(6) hospital uk.Skintact electrodes model t-vo01 were used.The initial reporter was requiring "please could you inform me whether the above electrode contains nickel or latex, we have a patient who is highly allergic." after several requests we have been informed that the "lady had a temporary skin reaction which has now resolved.She is known to have a nickel and latex allergy." further on we have been informed that "she did not need any treatment of the skin reaction." 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: 12826092
• MDR Text Key: 280940445
• Report Number: 8020045-2021-00022
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531505487
• UDI-Public: (01)19005531505487
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K023503
• 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: 11/30/2021

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: T-VO01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 11/30/2021
• 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 Sex: Female