MAUDE Adverse Event Report: LEONHARD LANG GMBH STABLE BASE ; ECG ELECTRODE

Model Number T60

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 05/07/2015

Event Type  Injury  

Manufacturer Narrative

Our distributor received a total of nine complaints from the same sub-distributor.They informed us these had been collected over a period of time but complained together.We consider four of them as (potentially) reportable and are filing separate mdr's for each one of these.Retained samples of the same lot were inspected visually, mechanically and for their ph.In addition, four electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.The pt used a solvent (alcohol) to clean the skin prior to ecg and placed electrodes on skin sites that had developed raw spots and skin irritations.We therefore conclude that user errors caused or at least influenced the severity of the injuries.

Event Description

On (b)(6) /2015, we have been informed about an incident with ecg electrodes.A monitoring ecg electrodes (model sbt60) and a mct ecg machine had been used.The pt's skin type was described as normal, no hair.The body type was described as athletic/slim with soft and alive skin the general state was described as normal.Four electrodes were applied to the chest area.The electrodes were initially changed on a daily basis and new electrodes applied on the same locations.Between uses the skin was cleaned and disinfected with alcohol and lotion.In the course of the study the pt developed skin irritations underneath the adhesive area ("all four electrode spots raw - one spot infected looking").The pt used alcohol to remove adhesive residues from his skin.The topical use of alcohol and lotion irritated his skin even more.The pt treated the infected looking spot afterwards witch bacitracin antibiotic ointment.

Manufacturer Narrative

Our distributor received a total of nine complaints from the same sub-distributor.They informed us these had been collected over a period of time but complained together.We consider four of them as (potentially) reportable and are filing separate mdrs for each one of these.Retained samples of the same lot were inspected visually, mechanically and for their ph.In addition, four electrodes were applied on a volunteer for six hours.No reaction or deviation cold be observed.The ifu explicitly states: "do not use solvents to clean skin prior to ecg (.)." "do not place electrodes on skin sites with (.) injuries of any kind." do no use on patients with shown skin irritating effects on skin (.)." the patient used a solvent (alcohol) to clean the skin prior to ecg and placed electrodes on skin sites that had developed raw spots and skin irritations.It was not possible to receive any further information despite repeated requests.No conclusion regarding the cause of the incident can be drawn.We therefore consider the investigation closed.

• Brand Name: STABLE BASE
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck 6020 ; AU 6020
• Manufacturer Contact: burrhus lang ; archenweg 56; innsbruck 6020 ; AU 6020 ; 12334257
• MDR Report Key: 5077967
• MDR Text Key: 25896525
• Report Number: 8020045-2015-00059
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2015

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: Other
• Device Expiration Date: 11/30/2016
• Device Model Number: T60
• Device Catalogue Number: SBT60
• Device Lot Number: 41104-0159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2015
• Initial Date FDA Received: 09/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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: 60 YR
• Patient Weight: 88