MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; MULTIFUNCTION DEFIBRILLATION ELECTRODE

Model Number DF43N

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

As no lot number was provided for this incident, no tests could be performed on retained samples.Reddening is a regular consequence of a cardioversion procedure.However, the images are not fully conclusive and we cannot rule out that it was caused by an allergy or the reported skin sensitivity of the patient.We are not sure this constitutes a reportable incident but file this mdr to err on the safe side.We consider this complaint closed.

Event Description

On (b)(6), we have been informed about a skin reaction with a defibrillation electrode in a hospital in (b)(6).A cardioversion procedure was performed using a skintact defibrillation electrode set (model df43n) and a nihon kohden cardiolife defibrillator.The patient was described as obese and the skin type as dry.The initial report mentioned that the patient indicated before the treatment to have very sensitive skin.It was reported that the patient was not hairy at the placement sites and the electrodes were adhering well to the patient skin.The patient skin was not cleaned, not shaven, not dried, not disinfected and no ointment had been used.After the procedure skin "reddening" was detected underneath the defibrillation electrodes.Photos of the reddening were taken right after the procedure and sent to us.The reddened areas of the skin seem to have formed at the outside edge of the adhesive foam of the electrodes as well as underneath the edge of the conductive gel a few mm deep (but sometimes reaching a few cm into the conductive area).It is unclear whether the reddening was the result of an allergy or an expected (normal) side effect of the procedure.The injury was treated with "local flamazine cream for some days.".

• Brand Name: SKINTACT
• Type of Device: MULTIFUNCTION DEFIBRILLATION 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: burrhus lang ; archenweg 56; 6020 innsbruck; innsbruck, tirol 6020 ; AU 6020 ; 512 334254
• MDR Report Key: 5595357
• MDR Text Key: 43270987
• Report Number: 8020045-2016-00013
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K142803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DF43N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• 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 Age: 67 YR
• Patient Weight: 96