MEDISLIM Adverse Event — Injury (MDR MW5094279)
MEDISLIM Adverse Event — Injury (MDR MW5094279) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MEDISLIM; Generic name: POWERED LASER SURGICAL INSTRUMENT; Manufacturer: MEDICREATIONS, LLC.
| Device | MEDISLIM |
|---|---|
| Generic name | POWERED LASER SURGICAL INSTRUMENT |
| Manufacturer | MEDICREATIONS, LLC |
| Report number | MW5094279 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | THIS COMPLAINT RELATES TO THE IMPROPER MARKETING AND INADEQUATE LABELING OF AN UNLICENSED MEDICAL DEVICE BY MEDICREATIONS OF (B)(4). MEDICREATIONS CLAIMS TO BE AN AMERICAN MANUFACTURER; YET, ALL OF ITS PRODUCTS ARE DESIGNED AND/OR CREATED IN (B)(4) (PLEASE SEE THEIR 510(K) PREMARKET NOTIFICATIONS K080382, K161286, K161692, K161925, AND K161926.) THE PARTICULAR DEVICE WHICH IS THE SUBJECT OF THIS C |
| Source | openFDA MAUDE (device adverse events) |
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