MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-16 for STABLE BASE W-601 SBT601 manufactured by Leonhard Lang Gmbh.
[142225663]
Retained samples of the 4 different lot/batches of item t-601 [di portion: (b)(4)] (180222-0258, 180316-0259, 180326-0253, 180328-0254) and 10 different lot/batches of item w-601 [di portion: (b)(4)] (180221-0257, 180223-0259, 180305-0072, 180309-0255, 180330-0255, 180403-0256, 180416-0156, 180417-0157, 180425-0152, 180524-0075) have been inspected visually and electrically. Mechanical tests were performed on 4 retained samples of each lot number. All tested samples were found to perform within limits. No faults could be detected. The complaints were gathered by the sub-distributors over a period of 3 months and submitted to our distributor. Considering an earlier complaint originating from the same sub-distributor (reported as mdr 8020045-2018-00026) the annual number of cases can be estimated to be between 100 and 120. Leonhard lang manufactures and distributes (b)(4) electrodes of the models t-601 and w-601 per year (2018), (b)(4) of which have been distributed to the particular sub-distributor. This constitutes (b)(4) of the total. During the last twelve months no other complaints for skin irritation have been received regarding these two electrode models from sources other than the sub-distributor. We therefore assume that an additional parameter or circumstances yet unknown are causal for the increased incidence of skin irritations. The investigation is ongoing. We will provide a follow-up report once additional information has become available.
Patient Sequence No: 1, Text Type: N, H10
[142225666]
On (b)(4) 2018, we have been informed about several incidents with ecg electrodes. Monitoring ecg electrodes (model sbw601 and sbt601) had been used with a verity ecg monitor. The initial report stated that "patients reported severe skin irritation with open sores and/or bleeding. There were 26 accounts from (b)(6) 2018 to (b)(6) 2019. (... ) some patients discontinued use to awaiting healing or more information from physician and others were sent electrodes that are more sensitive, if possible, to try. " the report referred to 26 separate cases, involving a total of 4 different lot/batches of item t-601 (50814) and 10 different lot/batches of item w-601 (50809). No further information was provided if and how the injuries had to been treated after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020045-2019-00007 |
| MDR Report Key | 8518352 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date Mfgr Received | 2019-03-02 |
| Date Added to Maude | 2019-04-16 |
| 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 | STABLE BASE |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-04-16 |
| Model Number | W-601 |
| Catalog Number | SBT601 |
| Lot Number | 180221-0257 |
| 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 | 2019-04-16 |