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

Model Number T-60

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 03/26/2015

Event Type  Injury  

Event Description

On(b)(6) 2015, an ecg monitoring procedure was performed.An ecardio verite-mct monitor and stable base sbt60 ecg electrodes were used.The duration of the procedure was 17 days.The skin type was described as fair to medium tone and the general state as normal - pear shape, carries weight in middle.The pt medical history was described as previous sensitivity to medical tape - specific type unk.The skin was "showered as normal" and dried.The skin has not been disinfected, not been shaven.The pt was discovered to have developed skin reactions: "felt burning after application.Removed (1 day later) in the shower; they come off easily.There was redness, like a sunburn at first.It kept getting redder and redder.The skin started to peel less than a week after removal, then skin welled with raised bumps that looked like poison ivy about 2 weeks after removal began to itch really bad".The size of the injury was described as a one inch circle.It was also reported that the electrodes were applied on the patient's upper chest and under breasts.The injury had the size and shape of electrode.The skin reaction was treated with hydrocortisone with calamine and benadryl cream.

Manufacturer Narrative

Retained samples of the same lot were inspected visually and for their ph.In addition, one electrode was applied on a volunteer for six hours.No reaction or deviation could be observed.The retained samples were within specification.No further incidents have been reported to us of the involved lot number in question.It appears a user error at least contributed to the incident.The ifu states "do not use on patients with shown skin irritating effects in direct electrodes contact.".According to the questionnaire it had been known that there was an incompatibility to medical tape.The adhesive carrier of the electrode is made of a medical adhesive tape.No further conclusions can be drawn.

• Brand Name: STABLE BASE
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck ; AU
• Manufacturer Contact: burrhus lang ; archenweg 56; innsbruck 6020 ; AU 6020 ; 12334257
• MDR Report Key: 4810471
• MDR Text Key: 5921565
• Report Number: 8020045-2015-00044
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

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: 10/31/2014
• Device Model Number: T-60
• Device Catalogue Number: SBT60
• Device Lot Number: 41001-0151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 55 YR
• Patient Weight: 64