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

Device Problem Missing Information (4053)

Patient Problems Rash (2033); Skin Irritation (2076)

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 additional information several times and are awaiting further information as promised in the last e-mail dated august 2nd.No conclusion can be drawn what might have caused the skin reaction yet.We will file a follow-up report as soon as we get further information.

Event Description

On (b)(6) 2018 we have been informed about an incident with ecg electrodes in the (b)(6).An unknown electrode model had been used for holter monitoring.Neither an electrode model nor a lot number were provided.The electrodes were put on the patient at (b)(6) hospital, (b)(6).The complainant (patient) reported that she had "a big reaction" to the gel of the electrode.She did not take a picture of the reaction but described it as "a red circle with small water filled blisters inside.It was from the gel contact rather than the adhesive." the complainant further stated that she "had a reaction in the past as well, when i had another 72 hr and 7 day holster".We have requested additional information on the electrodes used (model and lot number).However, the patient was not able to provide that information.The patient is currently on holiday and has not yet returned a questionnaire, which was sent to her.

Manufacturer Narrative

As neither a lot number nor samples have been made available to us, no analyses could be performed so far.In an e-mail dated august 2nd mrs.Page was promising further information after her holidays.After several requests mrs.Page contacted us on august 19th: "i'm back from holiday now but unable to find the forms to complete in the email trail.Could you send them again please" on august 20th we have again sent the questionaire to mrs page.On september 10th e-mail request for the questionaire.E-mail reminder on septermber 14th.E-mail reminder on septermber 25th.E-mail reminder on october 01st.We also have pointed out that we will close the complaint if no further information will be received in the next 14 days.As no further information is available no further invesigation can be carried out and no conclusion can be drawn as to what might have caused the claimed problems.We therefore close the investigation.

Event Description

On (b)(6)2018 we have been informed about an incident with ecg electrodes in the uk.An unkown electrode model had been used for holter monitoring.Neither an electrode model nor a lot number were provided.The electrodes were put on the patient at william harvey hospital, ashford, uk.The complainaint (patient) reported that she had "a big reaction" to the gel of the electrode.She did not take a picture of the reaction but described it as "a red circle with small water filled blisters inside.It was from the gel contact rather than the adhesive." the complainant further stated that she "had a reaction in the past as well, when i had another 72hr and 7 day holster".We have requested additional information on the electrodes used (model and lot number).However, the patient was not able to provide that information.The patient is currently on holiday and has not yet returned a questionnaire, which was sent to her.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 7761046
• MDR Text Key: 116370589
• Report Number: 8020045-2018-00015
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other