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

Device Problem Insufficient Information (3190)

Patient Problem Skin Discoloration (2074)

Event Type  Injury  

Manufacturer Narrative

As no lot number was provided, no tests cold be performed on retained samples.Due to the lack of info, we are unable to establish, if these distinct dark mark constitutes a reportable injury.We will try to obtain add'l info and will provide a follow up report, when we receive it.

Event Description

On (b)(6) 2015, we have been informed about an incident w/ecg electrodes.Short term was placed on the left thigh.It was reported tht no hair was underneath the electrodes (unknown model) were used.No lot number was provided.The complainant reported, "the patient has reported a distinct dark mark on her skin where the electrodes had been placed and this has not gone away despite the electrodes being removed just over a month ago.The electrodes were in situ for approximately 16 hours and the patient does not report any known allergies or skin lesions." no further info was provided despite repeated requests.

Manufacturer Narrative

As no lot number was provided, no tests could be performed on retained samples.After several requests for further information we were not able to obtain any.Our distributor informed us: "we have not been able to obtain any photographs or samples regarding this incident.We have supplied the list of ingredients of the gel of ftbi as requested.Therefore we consider this complaint closed." no further conclusion can be drawn what has caused the distinct dark mark of the patient and if this distinct dark mark constitutes a reportable injury.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck ; AU
• Manufacturer Contact: burrhus lang ; archenweg 56; innsbruck ; AU ; 12334257
• MDR Report Key: 5038437
• MDR Text Key: 24542176
• Report Number: 8020045-2015-00055
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/25/2015

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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