MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for ILIGHT IPL6750 manufactured by Shaser, Inc..
[120690119]
Patient Sequence No: 1, Text Type: N, H10
[120690120]
A consumer from (b)(6) region reported a burn injury when using model# ipl6750 and returned the device to the shop.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005855240-2018-00001 |
| MDR Report Key | 7887204 |
| Date Received | 2018-09-18 |
| Date of Report | 2018-07-23 |
| Date of Event | 2017-04-24 |
| Date Facility Aware | 2017-07-19 |
| Report Date | 2017-07-23 |
| Date Reported to FDA | 2017-07-23 |
| Date Reported to Mfgr | 2017-07-23 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2018-09-18 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 8123 FORSYTHIA ST SUITE 120 |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6082786362 |
| Manufacturer G1 | SHASER, INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILIGHT IPL6750 |
| Generic Name | IPL6750 |
| Product Code | ONF |
| Date Received | 2018-09-18 |
| Returned To Mfg | 2017-07-19 |
| Model Number | IPL6750 |
| Catalog Number | IPL6750 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHASER, INC. |
| Manufacturer Address | 8123 FORSYTHIA STREET SUITE 120 MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-18 |