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

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

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.As no lot number was provided for this incident, no tests could be performed on retained samples.Despite of repeated requests from us the initial reporter was not able to supply us with more info on the involved product and on the treatment of the injury afterwards.No conclusion regarding the cause of the skin reaction can be drawn.We will provide a follow up report when we will receive additional info.

Event Description

On 08/11/2015, we have been informed about an incident with ecg electrodes.No lot number was provided.No info on the procedure was provided.The pt's skin type was described as normal sensitive.The skin was cleaned with saline water, not shaven, not disinfected, and dried.The general state of the pt was described as dizzy and faint.The questionaire's question "data on medication of the pt that could cause or contribute to skin reactions" was answered with "yes".However, no further details were provided.The electrodes were applied to the chest area.The pt discovered peeling skin and bruises where the electrodes had been ("underneath the adhesive area").On one location the skin was bleeding.It is not clear, whether the injury developed when the injury developed as inconclusive info was provided ("right away - on she didn't know until she removed" and "a couple of days after [the treatment]".No further info on how the skin was treated afterwards have been reported to us.

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.As no lot number was provided for this incident, no tests could be performed on retained samples.Despite of repeated requests from us the initial reporter was not able to supply us with more information on the involved product and on the treatment of the injury afterwards.No conclusion regarding the cause of the skin reaction can be drawn.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.

Event Description

On (b)(6) 2015 we have been informed about an incident with ecg electrodes.No lot number was provided.No information on the procedure was provided.According to the report four or five electrodes were used.The patient's skin type was described as sensitive.The skin was cleaned with saline water, not shaven, not disinfected, and dried.The general state of the patient was described as dizzy and faint.The questionaire's question "data on medication of the patient that could cause of contribute to skin reactions" was answered with "yes".However, no further details were provided.The electrodes were applied to the chest area.The patient discovered peeling skin and bruises where the electrodes had been ("underneath the adhesive area").On one location, the skin was bleeding.It is not clear whether the injury developed when the injury developed as inconclusive information was provided ("right away - on she didn't know until she removed" and "a couple of days after (the treatment)".No further information on how the skin was treated afterwards have been reported to us.

• 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: 5077974
• MDR Text Key: 25904489
• Report Number: 8020045-2015-00056
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 85