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

Model Number FS50

Device Problem Insufficient Information (3190)

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.No conclusion regarding the cause of the skin injury can be drawn so far.We have requested further information (skin preparation, treatment of the skin reaction) and will provide a follow up report upon receipt.

Event Description

On april 18th, 2019, we have been informed about an incident with ecg electrodes.Monitoring ecg electrodes (model fs50) and an unknown heart monitoring recorder had been used.The initial reporter stated "i have a case of a nasty allergic person".The initial reporter also provided 3 photos showing a male patient's chest area with 5 round reddish skin reactions.No further information was provided if and how the injury had to be treated.We are requesting further information on the patient, the skin preparation, the procedure, the wearing duration and how the injury had to be treated.

Manufacturer Narrative

The retained samples of the claimed lot number has been inspected visually and electrically.Mechanical tests were performed on 4 samples of the retained samples.All tested samples were found to perform within limits.No faults could be detected.The concerned lot number has in total a production amount of (b)(4) electrodes.These electrodes have been sold to only one distributor.No further incidents have been reported regarding the concerned lot number.Reviewing the provided 3 photos showing a male patient's chest area with 5 round reddish skin reactions we assume the patient injury is no injury which has to be treated by a medical intervention to prevent a permanent impairment of a body structure.However as we have no information about a treatment afterwards we only could speculate about that.No conclusion regarding the cause of the skin reaction can be drawn.

Event Description

On (b)(6)2019, we have been informed about an incident with ecg electrodes.Monitoring ecg electrodes (model fs50) and a dräger heart monitoring recorder had been used at kantonsspital obwalden in switzerland.We have received a completed questionaire.A surgical procedure at the patient's leg was performed.The patient was described as of athletic body type and normal skin.His general state was described as normal.No cleaning of the skin, no shaving, no disinfectant or ointment had been used for preparing the skin.No injury or skin lesion was present before applying the ecg electrodes.5 ecg electrodes were applied in total to the patient's chest.The duration of monitoring lasted for about 2 hours.The electrodes adhered properly no issues relating the adhesion force were noted.After the treatment an allergic reaction was detected.The initial reporter also provided 3 photos showing a male patient's chest area with 5 round reddish skin reactions.No further information was provided if and how the injury had to be treated.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 8611700
• MDR Text Key: 145107016
• Report Number: 8020045-2019-00009
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2021
• Device Model Number: FS50
• Device Lot Number: 190107-0227
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 78