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

Model Number T60

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 04/29/2015

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 mdrs for each one of these.Retained samples of the same lot were inspected visually, mechanically and for their ph.In addition, four electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.Despite of repeated requests from us the initial reporter was not able to supply us with more info 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 (b)(6) 2015, we have been informed about an incident with ecg electrodes (model t60).A 30 days monitoring was performed.The pt's skin type was described as normal, no hair.The skin was described as clean, not shaven, not disinfected, no ointment was used and dried.The general state of the pt was described as normal.We have been informed that the medical history oft eh pt ("that could cause or contribute to skin reactions") was described as very sensitive.Four electrodes were applied to the chest area.After 8 hours the pt disconnected the electrodes because she had developed a rash.Upon removing the electrodes she discovered "whelps, broken skin, burning, bleeding, itching and puss" "underneath and around the outside of the electrodes".No further info on the skin treatment afterwards have been reported to the date.

Manufacturer Narrative

Our distributor received a total of (b)(4) 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.Retained samples of the same lot were inspected visually, mechanically and for their ph.In addition, four electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.Despite of repeated requests from us, the initial reporter was not able to supply us with more info 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 info 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 (model t60).A 30 days monitoring was performed.The pt's skin type was described at normal, no hair.The skin was described as clean, not shaven, not disinfected, no ointment was used and dried.The general state of the pt was described as normal.We have been informed that the medical history of the pt ("that could cause or contribute to skin reactions") was described as very sensitive.Four electrodes were applied to the chest area.Ater 8 hours the pt disconnected the electrodes because she had developed a rash.Upon removing the electrodes she discovered "whelps, broken skin, burning, bleeding, itching and puss "underneath and around the outside of the electrodes".No further info on the skin treatment afterwards have been reported to the date.

• 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: 5077969
• MDR Text Key: 25900562
• Report Number: 8020045-2015-00058
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 024247
• 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
• Device Expiration Date: 10/31/2016
• Device Model Number: T60
• Device Catalogue Number: SBT60
• Device Lot Number: 41030-0157
• 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
• Date Device Manufactured: 10/01/2014
• 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: 53 YR
• Patient Weight: 136