MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-06-26 for ILIGHT IPL6500 manufactured by Shaser Inc.
| Report Number | 3005855240-2019-00001 |
| MDR Report Key | 8737821 |
| Report Source | CONSUMER |
| Date Received | 2019-06-26 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-04-15 |
| Report Date | 2019-06-26 |
| Date Reported to FDA | 2019-06-26 |
| Date Reported to Mfgr | 2019-06-26 |
| Date Mfgr Received | 2019-05-29 |
| Date Added to Maude | 2019-06-26 |
| 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. LAVEE YANG |
| Manufacturer Street | 3001 DEMING WAY |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6082786362 |
| Manufacturer G1 | SHASER INC |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILIGHT IPL6500 |
| Generic Name | IPL6500 |
| Product Code | ONF |
| Date Received | 2019-06-26 |
| Model Number | IPL6500 |
| Catalog Number | IPL6500 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHASER INC |
| Manufacturer Address | 3001 DEMING WAY MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-26 |