MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-25 for I-LIGHT PRO IPL6500 manufactured by Shaser Inc.
| Report Number | 3005855240-2016-00002 |
| MDR Report Key | 5903365 |
| Date Received | 2016-08-25 |
| Date of Report | 2016-10-28 |
| Date of Event | 2016-07-21 |
| Date Facility Aware | 2016-07-21 |
| Report Date | 2016-10-28 |
| Date Reported to FDA | 2016-10-28 |
| Date Reported to Mfgr | 2016-10-28 |
| Date Mfgr Received | 2016-07-21 |
| Date Added to Maude | 2016-08-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LETICIA BOOTH |
| Manufacturer Street | 81 HARTWELL AVE |
| Manufacturer City | LEXINGTON MA 02421 |
| Manufacturer Country | US |
| Manufacturer Postal | 02421 |
| Manufacturer Phone | 7819953528 |
| Manufacturer G1 | SHASER INC |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | I-LIGHT PRO IPL6500 |
| Generic Name | IPL6500 |
| Product Code | ONF |
| Date Received | 2016-08-25 |
| Returned To Mfg | 2016-08-12 |
| Model Number | IPL6500 |
| Catalog Number | IPL6500 |
| Lot Number | 13 |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHASER INC |
| Manufacturer Address | 81 HARTWELL AVE LEXINGTON MA 02421 US 02421 |