MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2010-04-29 for SKINTACT WR01 manufactured by Leonhard Lang Gmbh.
[21682520]
On 03/25, we have been informed about an injury of a pt at hospital (b) (6). The date and nature of the surgery are still unk to us. A non-monitoring dispersive electrode (model wr01) and a electrosurgical generator (no model has been revealed) were used. No info of the size and the degree of the burn, how it was treated afterwards, how the skin was prepared, the orientation of the electrode, the generator model, the power setting used could be obtained so far.
Patient Sequence No: 1, Text Type: D, B5
[21822385]
The device involved in the incident was returned in a plastic container without lid, which was placed in a transparent plastic bag. The device involved and the retained samples of the same lot have been visually inspected and tested electrically and thermally. The retained samples were tested for their adhesion as well. All test results were within limits with the exception of the thermal test of the device involved in the incident. It showed a maximum temperature rise of 6. 6 degrees k, which is 10% above the acceptable value for a unused dispersive electrode kept in its original packaging at the recommended storage conditions. We therefore, assume that the involved electrode was within specs at the time of the incident and the 10% deviation is a result of the product having been used, partially burned, and then been kept and transported in a non-steamproof environment. The device involved in the incident shows a burn mark of 1 x 3 cm located on the low end of the right side of the electrode when viewed from the gel side (connecting tab up). No conclusion can be drawn so far. We will continue to ask for further info and will relay such info and any conclusion in a f/u report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020045-2010-00006 |
| MDR Report Key | 1672802 |
| Report Source | 01,08 |
| Date Received | 2010-04-29 |
| Date of Report | 2010-04-22 |
| Date Mfgr Received | 2010-03-25 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2010-05-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. BURRHUS LANG |
| Manufacturer Street | ARCHENWEG 56 |
| Manufacturer City | INNSBRUCK 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal | 6020 |
| Manufacturer Phone | 12334257 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKINTACT |
| Generic Name | ELECTROSURGICAL GROUNDING PLATE |
| Product Code | ODR |
| Date Received | 2010-04-29 |
| Returned To Mfg | 2010-04-01 |
| Model Number | WR01 |
| Lot Number | 91021-0803 |
| Device Expiration Date | 2012-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-04-29 |