MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-05-15 for XLBLEU TVO01 XL-TVO01 manufactured by Leonhard Lang Gmbh.
[145106835]
The user has named two lot numbers, 180823-0241 and 180618-0245, and has returned a pouch each for further investigation. Retained and returned customer samples of both lot numbers have been inspected visually and tested mechanically. Mechanical tests were performed on 4 samples of the retained and returned customer samples of each lot number. All tested samples were found to perform within limits. No faults could be detected. We have additionally performed a skin wear test on 3 probands for each lot number with retained and returned customer samples for 6 hours. No failure was detected when wearing the electrodes on all probands. No conclusion regarding the cause of the skin injury can be drawn so far. We have requested further information (skin preparation, duration of wearing, treatment of the skin reaction) and will provide a follow up report upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[145106836]
On april 15th, 2019, we have been informed about incidents with ecg electrodes. Monitoring ecg electrodes (model tvo01) and unknown heart monitoring recorders had been used. The initial reporter stated "department have been using xl-tvo01 for over 12 months, staff have received complaints from patients saying the electrodes are causing 'skin reactions' (one patient had to have steroid cream the reaction was so bad) the analysis/readings from the tapes have been fine the issue is with the adhesion on the micropore". We are requesting further information on the patient, the skin preparation, the procedure, the wearing duration and how the injuries had to be treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020045-2019-00011 |
| MDR Report Key | 8611711 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-28 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2018-08-23 |
| Date Added to Maude | 2019-05-15 |
| 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 | 2019-05-15 |
| Model Number | TVO01 |
| Catalog Number | XL-TVO01 |
| Lot Number | 180823-0241 |
| Device Expiration Date | 2018-08-23 |
| 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, 6020 AU 6020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-15 |