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 2019-01-21 for SKINTACT F-55 manufactured by Leonhard Lang Gmbh.
[133720703]
As neither a lot number nor samples have been made available to us, no analyses could be performed so far. The physician has asked for ingredients of the electrode to determine if an allergy has caused the reaction. No conclusion regarding the cause of the skin injury can be drawn so far. We have requested further information (skin preparation, treatment of rash) and will provide a follow up report upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[133720704]
On (b)(4) 2018, we have been informed about an incident with ecg electrodes. Monitoring ecg electrodes (model f55) and an unknown heart monitoring recorder had been used. The initial reporter stated "i saw a patient who developed a skin rash after holter monitoring for 24 hours with the skintact ecg electrodes (f-55, aqua wet type). The skin rash was exactly on the sites of ecg electrode fixation the day before. We would like to know the ingredients of the gel/foam in the central part of the skintact ecg electrodes. Is this substance perfumed? Does it contain acrylates or other products? " no further information was provided if and how the injury had to been treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020045-2019-00002 |
| MDR Report Key | 8263911 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-01-21 |
| Date of Report | 2019-02-28 |
| Date Mfgr Received | 2018-12-18 |
| 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-55 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |