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

Model Number FSTC1

Device Problem Insufficient Information (3190)

Patient Problem Local Reaction (2035)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

Retained samples of the same lot number were inspected visually and mechanically.In addition, two electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.The retained samples were within specification.It is yet unknown whether the skin reaction occurred underneath the electrode's tape or underneath it's gel.No information how the skin was prepped has been provided so far.It is also unclear whether "hurt" and "reddish skin" constitute injuries and whether they had to be treated.It was not possible to receive this information despite repeated requests.We will continue to request further information and will provide any findings in a follow up report.Device not returned.

Event Description

On (b)(4) 2017, we have been informed about a skin reaction during an ecg procedure.Monitoring ecg electrodes model sofmed f-tc1 have been used.The initial report stated that removing the electrodes "hurt [a] patient and [he/she] got reddish skin." no further details have been disclosed so far despite of repeated requests.

Manufacturer Narrative

Retained samples of the same lot number were inspected visually and mechanically.In addition, two electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.The retained samples were within specification.No further incidents have been reported to us involving the complained lot number.The complaint was limited to a reaction of a single patient.The nature of the medical intervention performed to treat the observed redness was not disclosed to us.No conclusions as to the cause of the skin reactions can be drawn.We therefore close the complaint.

Event Description

On (b)(6) 2017, we have been informed about a skin reaction during an ecg monitoring procedure.Monitoring ecg electrodes model sofmed f-tc1 have been used.The patient's body type was described as athletic and the skin type as "normal".The skin was cleaned, shaven and dried.6 electrodes were applied in the chest area.The skin has not been disinfected and no ointmnet had been used.The electrodes adhered properly.When the patient removed the electrodes after the procedure, redness were detected underneath the adhesive area the 6 applied electrodes.The size of the injuries was characterized as "spots".It was reported that the injuries were treated by a "medical intervention".

• Brand Name: SOFMED
• 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: burrhus lang ; archenweg 56; innsbruck, tirol 6020 ; AU 6020 ; 5123342541
• MDR Report Key: 7056808
• MDR Text Key: 92835245
• Report Number: 8020045-2017-00026
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

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 Expiration Date: 03/31/2019
• Device Model Number: FSTC1
• Device Catalogue Number: F-TC1
• Device Lot Number: 170314-0305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2017
• 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: 45 YR
• Patient Weight: 75