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

Model Number T-VO01

Device Problem Insufficient Information (3190)

Patient Problems Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545)

Event Date 06/20/2022

Event Type  Injury  

Event Description

We have been informed on (b)(6) 2022, about an incident involving ecg-electrodes at (b)(6).(b)(4) electrodes catalogue model asw72 (leonhard lang model: tvo01) have been used.The initial reporter stated that [translated from (b)(6) language to english language]: "in two long-term ecgs with different patients, a customer was able to determine a skin damage in the chest area after treatment, whereby the damage indicates a burn.The dorsal derivation is in each case without abnormalities.The storage took place in the box or in the sealed pouches in the department at normal temperatures.Both patients have no known allergies or abnormalities of their skin.There was no special skin preparation, in the case of heavy sweating, a short disinfection followed by a drying phase was carried out however, it is unclear whether this had happened in these two cases.The chest hair was not shaven in any of the two cases." we have received for both patients a partially filled in questionnaire.For the first patient (ref.In the questionaire: no.(b)(4)) it was specified: age: 68 years, female, patient weight: 70kg on (b)(6) 2022 a 24 hour long-term ecg monitoring was performed.The patient was described as normal built and the skin type also as normal.The medical history indicated diabetes mellitus type 2.The patient skin was not cleaned, not shaven, not disinfected and no skin ointment have been used.The skin was dried before attaching the ecg electrodes.4 electrodes have been applied to the patients chest.Underneath 3 electrodes an injury was detected after the procedure at the outer adhesive tape edge of the electrodes.The injury was described as circular redness with partial blistering.The injury was treated with prednisolone 20mg for 5 days.For the second patient (ref.In the questionaire: no.(b)(4)) it was specified: age: 62 years, male, patient weight: 76kg.On (b)(6) 2022 a 24 hour long-term ecg monitoring was performed.The patient was described as normal built and the skin type also as normal.The medical history indicated no allergies or other diseases that affect the skin.The patient skin was not cleaned, not shaven, not disinfected and no skin ointment have been used.The skin was dried before attaching the ecg electrodes.4 electrodes have been applied to the patients chest.Underneath 3 electrodes an injury was detected after the procedure at the outer adhesive tape edge of the electrodes.The injury was described as circular redness with partial blistering.The injury was treated with prednisolone for 5 days.

Manufacturer Narrative

Retained samples of the concerned lot number have been inspected visually, mechanically and electrically.No faults were detected.We have requested the involved device but it has not yet been made available to the date of this report.Currently no conclusion can be drawn what might have caused the claimed problem.We will further investigate and relay any conclusion in a follow up report.

Manufacturer Narrative

Retained samples of the concerned lot number have been inspected visually, mechanically and electrically.No faults were detected.We have requested the involved device respectively samples of the concerned lot number but it has not yet been made available.We have requested further information on the skin preparation and used agents and have been informed that [translated from german to english language]: "we do not treat the skin with disinfectant or other cleaning agents before sticking the electrodes.Only after a shave or when the patient sweats do we use disinfectants before.(.) there has been no feedback of any skin irritation after using the newly sent electrodes.".No other user has reported a similar complaint.We could not draw any conclusion what might have caused the claimed problem.No further details have been received we therefore consider the investigation closed.

Event Description

We have been informed on june 28th, 2022, about an icident involving ecg-electrodes at (b)(6) in germany.Asmuth electrodes catalogue model asw72 (leonhard lang model: tvo01) have been used.The initial reporter stated that [translated from german language to english language]: "in two long-term ecgs with different patients, a customer was able to determine a skin damage in the chest area after treatment, whereby the damage indicates a burn.The dorsal derivation is in each case without abnormalities.The storage took place in the box or in the sealed pouches in the department at normal temperatures.Both patients have no known allergies or abnormalities of their skin.There was no special skin preparation, in the case of heavy sweating, a short disinfection followed by a drying phase was carried out however, it is unclear whether this had happened in these two cases.The chest hair was not shaven in any of the two cases.".We have received for both patients a partially filled in questionnaire.For the first patient (ref.In the questionaire: no.471776) it was specified: age: 68 years, female, patient weight: 70kg.On (b)(6) 2022 a 24 hour long-term ecg monitoring was performed.The patient was described as normal built and the skin type also as normal.The medical history indicated diabetes mellitus type 2.The patient skin was not cleaned, not shaven, not disinfected and no skin ointment have been used.The skin was dried before attaching the ecg electrodes.4 electrodes have been applied to the patients chest.Underneath 3 electrodes an injury was detected after the procedure at the outer adhesive tape edge of the electrodes.The injury was described as circular redness with partial blistering.The injury was treated with prednisolone 20mg for 5 days.For the second patient (ref.In the questionaire: no.471429) it was specified: age: 62 years, male, patient weight: 76kg.On (b)(6) 2022 a 24 hour long-term ecg monitoring was performed.The patient was described as normal built and the skin type also as normal.The medical history indicated no allergies or other diseases that affect the skin.The patient skin was not cleaned, not shaven, not disinfected and no skin ointment have been used.The skin was dried before attaching the ecg electrodes.4 electrodes have been applied to the patients chest.Underneath 3 electrodes an injury was detected after the procedure at the outer adhesive tape edge of the electrodes.The injury was described as circular redness with partial blistering.The injury was treated with prednisolone for 5 days.

• Brand Name: ASMUTH
• 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: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 15049961
• MDR Text Key: 296141225
• Report Number: 8020045-2022-00023
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 29005531001163
• UDI-Public: (01)29005531001163
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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: 09/15/2022
• Device Model Number: T-VO01
• Device Catalogue Number: ASMUTH ASW72
• Device Lot Number: 200915-0243
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White