MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-05-22 for XLBLEU manufactured by Leonhard Lang Gmbh.
[145747372]
As neither a model nor a lot number was provided for this incident, no tests could be performed on retained samples. We have requested further information (on the concerned product, the concerned lot number, the skin preparation, duration of wearing, treatment of the skin reaction) several times but we have not received any. The symptoms described indicate an allergic reaction to electrode contact. Due to the lack of information it was not possible to further differentiate whether it is a reaction to the acrylic adhesive of the adhesive or to the gel of the electrode. We assume the incident is related to the patients medical condition and not to a particular electrode or electrode batch as the patient had stated that he had reactions to a number of different models of ecg electrodes branded either skintact or xlbleu. No further investigation is possible without the information not provided despite of repeated requests. We therefore consider the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
[145747373]
On (b)(6) 2019, we have been informed about an incident with ecg electrodes (most likely in ireland), which had happened in 2018. Monitoring ecg electrodes were used. No specific model was announced it was stated "regarding fannin skintact xlbleu and other skintact electrodes". In an attachment of the initial reporter it was stated "i have reactions with and without prednisolone and the reaction normally starts within a few minutes of having the electrode stuck in me. I have no negative reactions to prednisolone and have been prescribed it several times due to asthma. My reaction is also more severe than just a rash, i get the following symptoms: rash, difficulty breathing much like an asthma attack, nausea, dizziness". We have requested for further information on the patient, the skin preparation, the procedure, the wearing duration and how the injuries had to be treated at the complainant itself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020045-2019-00012 |
| MDR Report Key | 8631239 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-22 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-22 |
| 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, 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 6020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XLBLEU |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-05-22 |
| 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, 6020 AU 6020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-22 |