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

Model Number	T-60
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Retained samples of the same lot number were inspected visually and mechanically.In addition, two electrodes were 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 u.S involving the complained lot number.No conclusions as to the cause of the skin reactions can be drawn.Device not returned.
Event or Problem Description
On (b)(6) 2017, we have been informed by (b)(6), about an incident involving an unknown ecg holter monitor and skintact t-60 ecg electrodes.A holter procedure of 48 hours was performed.The patient's body type was described as slim and the skin type as "normal".In her medical history copd and a latex allergy were listed.The skin was cleaned with skin prep (model smith & nephew skin prep) and dried.Five electrodes were applied in the chest area.The skin has not been disinfected and not been shaven.The electrodes adhered properly.When the patient removed the electrodes after the procedure, abrasions and redness were detected underneath the gel and the adhesive area of at least 4 of the applied electrodes.The size of the injuries was characterized as "quarter size spots".It was reported that no treatment was necessary for the injuries, "just monitoring site for increased redness + signs of infection".
Additional Manufacturer Narrative
Retained samples of the same lot number were inspected visually and mechanicaly.In addition, two electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.The retained samples were within specification.We received an already opened pouch with 11 electrodes for further investigation.The returned customer electrodes were visually investigated and revealed that they were totally dried out.The blue coloring of the sponge confirms the that the sponge had contained gel.No further testing could be performed on these returned samples because of the state they were in.No further incidents have been reported to us involving the complained lot number.No conclusions as to the cause of the skin reactions can be drawn.
Event or Problem Description
On (b)(6) 2017, we have been informed by (b)(6), about an incident involving an unknown ecg holter monitor and skintact t-60 ecg electrodes.A holter procedure of 48 hours was performed.The patient's body type was described as slim and the skin type as "normal".In her medical history copd and a latex allergy were listed.The skin was cleaned with skin prep (model smith & nephew skin prep) and dried.5 electrodes were applied in the chest area.The skin has not been disinfected and not been shaven.The electrodes adhered properly.When the patient removed the electrodes after the procedure, abrasions and redness were detected underneath the gel and the adhesive area of at least 4 of the applied electrodes.The size of the injuries was characterized as "quarter size spots".It was reported that no treatment was necessary for the injuries, "just monitoring site for increased redness + signs of infection".

• Brand Name: SKINTACT
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 6784131
• Report Number: 8020045-2017-00020
• Device Sequence Number: 1115551
• Product Code: DRX
• UDI-Device Identifier: 29005531580460
• UDI-Public: (01)29005531580460
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K024247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2017
• Device Model Number: T-60
• Device Lot Number: 151127-0328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/27/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR