MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-02-21 for SKINTACT FS-VM01 manufactured by Leonhard Lang Gmbh.
[136725957]
Retained samples of the concerned lot number were inspected visually, electrically and mechanically. All electrodes were within limits, no failure could be detected. No conclusion can be drawn as to why a skin tear occurred when removing one electrode. Based on the information available and the involved electrode not having been made available no further investigations can be performed. We therefore close the investigation.
Patient Sequence No: 1, Text Type: N, H10
[136725958]
On (b)(4) 2019, we have been informed about an incident with ecg electrodes at (b)(6). Monitoring ecg electrodes (model skintact fs-vm01) and a zoll heart monitoring recorder had been used. A 1 minute monitoring was performed. The patient was being treated for cancer of the lung. The general state of the patient at the time the incident occured were described as him having chest pains. It was described that a 12 lead ecg procedure was performed at the patient's home. Ten electrodes were applied to the patient. The patient's skin type was described as dry. The skin was not shaven, not disinfected, no ointment had been used. The electrodes were adhering properly to the patient. The reporter stated "when the crew were removing electrodes after ecg" (... ) skin pulled away from patients (... ) left forearm". The position of the electrode relative to the injury was reported as "in the middle af the contact area" of the electrode. The injury was described as a "2cm x 2cm skin tear presumed round". All other nine electrodes were removed without issues. The injury was "cleaned and dressed by a+e". It was reported that the "wound is healing well. On (b)(6) 2019 dressing removed + smaller lighter wound care applied".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020045-2019-00003 |
| MDR Report Key | 8357175 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-01-26 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2018-12-14 |
| Date Added to Maude | 2019-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-02-21 |
| Model Number | FS-VM01 |
| Lot Number | 181214-0234 |
| 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 | 2019-02-21 |