MAUDE Adverse Event Report: LEONHARD LANG GMBH XL BLEU; ECG ELECTRODE

Model Number T-VQ01

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

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 microporous tape or underneath it's gel.No information as to the way the skin was prepped has been provided so far.It is also unclear whether the skin reactions 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.

Event Description

On (b)(6) 2017, we have been informed about incidents with ecg electrodes.During ambulatory long term monitoring procedures by (b)(6) hospital, monitoring ecg electrodes model xl-tvo02 have been used.The initial report stated that in the last 6 months a great number of patients complained about severe skin reactions to skintact xlbleu elite xl-t-vo02.On (b)(6), the customer provided two affected lot numbers: 170505-0244 and 170215-0245.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 of the retained samples were applied on a volunteer for six hours.In november 2017 the customer returned samples for further investigation.The customer returned 5 different lot numbers each one pouch for investigation.These lot numbers are: 60525-0243, 161111-0249, 161213-0249, 170505-0244 and 170215-0245.The returned samples were inspected visually and tested mechanically.Two electrodes of each lot number of the returned samples were applied on a volunteer for six hours.No reaction or deviation could be observed.The retained and returned samples were within specification.The user was describing that the skin preparation was done using sani cloth chg 2% disinfectant.It was investigated, whether this disinfectant might have played a role in the incident.We have been informed by the distributor of the sani cloth 2% chg that this product is a class iia (european classification) ce marked medical device product, which is indicated for disinfection of hubs and ports (product codes xp00220 or xp00314).It was also stated "we do supply a product which is a cosmetic; indicated for use on skin.Our sani-cloth chg cleansing wipes contain the same ingredients as the medical device product and are indicated for cleaning small areas of intact skin (product code xp00315).This product does not have any claims, however it does contain chg which is a well known disinfectant.The common practice for using this type of wipe is a minimum of 15 seconds cleaning/15 seconds drying time, although each hospital may have their own protocols." being questioned about this, the complainant stated "our process for attaching the electrodes is to clean to the skin with the wipes as specified; with the skin allowed to air dry followed by light abrasion with a paper towel.The skin is fully dry before electrodes are attached." no conclusion can be drawn what might have caused to the patients' problems.

Event Description

On august 24th, 2017, we have been informed about incidents with ecg electrodes.During ambulatory long term monitoring procedures by (b)(6), monitoring ecg electrodes model xl-tvo02 have been used.The initial report stated that in the previous 6 months a great number of patients complained about severe skin reactions to skintact xlbleu elite xl-t-vo02.On (b)(6) the customer provided two affected lot numbers: 170505-0244 and 170215-0245.On october 5th we received a completed questionnaire.Due to data protection policies, it contained no patient specific data but covered the observed adverse reactions in general.It was reported that male and female patients with varied ages from early 30ies to 70ies have been involved.The skin types have been describes as different skin types.The skin was cleaned, disinfected with sani-cloth chg 2% (disposable disinfection wipes), when hairy patients have been shaven, the skin was dried and no ointment has been used.The general state of the patients was "normal & sweating".6 electrodes were placed on each patient for a 7 day event recorder application.The injuries occurred underneath the adhesive area and around on chest positions and v5.They were described as "redness, blisters, broken skin" and "bigger lesions on patients with skin sensitivities to all plasters where most part of the chest areas was red".There was no treatment of the injuries "documented, if the patients attended gp no information [was] given to the [reporting] department".

• Brand Name: XL BLEU
• 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: 6878301
• MDR Text Key: 86707580
• Report Number: 8020045-2017-00022
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

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: 05/31/2019
• Device Model Number: T-VQ01
• Device Catalogue Number: XL-TVO02
• Device Lot Number: 170505-0244 AND 170215-0245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• 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