MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-05-15 for SKINTACT FS50 manufactured by Leonhard Lang Gmbh.
[145107016]
As neither a lot number nor samples have been made available to us, no analyses could be performed. No conclusion regarding the cause of the skin injury can be drawn so far. We have requested further information (skin preparation, treatment of the skin reaction) and will provide a follow up report upon receipt.
Patient Sequence No: 1, Text Type: N, H10
[145107017]
On april 18th, 2019, we have been informed about an incident with ecg electrodes. Monitoring ecg electrodes (model fs50) and an unknown heart monitoring recorder had been used. The initial reporter stated "i have a case of a nasty allergic person". The initial reporter also provided 3 photos showing a male patient's chest area with 5 round reddish skin reactions. No further information was provided if and how the injury had to be treated. We are requesting further information on the patient, the skin preparation, the procedure, the wearing duration and how the injury had to be treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020045-2019-00009 |
| MDR Report Key | 8611700 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2019-05-15 |
| Date of Report | 2019-09-19 |
| Date Mfgr Received | 2019-04-18 |
| Device Manufacturer Date | 2019-01-07 |
| 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 | SKINTACT |
| Generic Name | ECG ELECTRODE |
| Product Code | DRX |
| Date Received | 2019-05-15 |
| Model Number | FS50 |
| Lot Number | 190107-0227 |
| 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 |