MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-01-21 for SKINTACT F-601C manufactured by Leonhard Lang Gmbh.
[133719064]
The user has provided a choice of two lot numbers: 170905-0812 and 180625-0186 for further investigation (it is not clear, which lot was actually involved in the incident). Therefore, retained and returned customer samples of both lot numbers have been inspected visually and electrically. Mechanical tests were performed on 4 samples of the retained and the returned customer samples. All tested samples were found to perform within limits. No faults could be detected. The two concerned lot numbers have in total a production amount of (b)(4) electrodes. These electrodes have been sold to 6 major customers. No further incidents have been reported regarding these lot numbers. No conclusion regarding the cause of the skin reaction can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[133719065]
On (b)(6) 2018, we have been informed about an incident with ecg electrodes (model f-601c, two potential lot numbers were provided) at galway clinic in ireland. Monitoring ecg electrodes (model f601c) and an ge monitoring system had been used. We have received a completed questionaire. A pulmonary vein isolation procedure was performed. The patient was described as of normal body type and normal skin. His general state was described as normal. No cleaning of the skin, no shaving, no disinfectant or ointment had been used for preparing the skin. No injury or skin lesion was present before applying the ecg electrodes. 12 ecg electrodes were applied in total to the patient's chest. The duration of monitoring lasted for about 3-4 hours. The electrodes adhered properly. After the treatment, redness and blisters were detected underneath the adhesive foam area of "2-3 electrodes". The injuries were pharmacologically treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020045-2019-00001 |
| MDR Report Key | 8263905 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-01-21 |
| Date of Report | 2019-01-21 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2018-06-25 |
| Date Added to Maude | 2019-01-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BURRHUS LANG |
| Manufacturer Street | ARCHENWEG 56 |
| Manufacturer City | INNSBRUCK, TIROL 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal | 6020 |
| Manufacturer G1 | LEONHARD LANG GMBH |
| Manufacturer Street | ARCHENWEG 56 |
| Manufacturer City | INNSBRUCK, TIROL 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 6020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKINTACT |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-01-21 |
| Model Number | F-601C |
| Lot Number | 180625-0186 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEONHARD LANG GMBH |
| Manufacturer Address | ARCHENWEG 56 INNSBRUCK, TIROL 6020 AU 6020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-21 |