MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-15 for STRATAPULSE NA manufactured by Shanghai Apolo Medical Tech Co Ltd.
[4630540]
Patient rec'd ipl treatment for leg vein which may have resulted in permanent scarring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005327046-2014-00002 |
| MDR Report Key | 3984635 |
| Date Received | 2014-07-15 |
| Date of Report | 2014-07-15 |
| Date of Event | 2013-09-13 |
| Date Facility Aware | 2014-06-17 |
| Report Date | 2014-07-15 |
| Date Reported to Mfgr | 2014-07-15 |
| Date Added to Maude | 2014-08-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 12585 OLD HIGHWAY 280 STE 103 |
| Manufacturer City | CHELSEA AL 350430000 |
| Manufacturer Country | US |
| Manufacturer Postal | 350430000 |
| Manufacturer G1 | MARKET TECHNOLOGIES INC |
| Manufacturer Street | 12585 OLD HIGHWAY 280 STE 103 |
| Manufacturer City | CHELSEA AL 35043000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 35043 0000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATAPULSE |
| Generic Name | IPL |
| Product Code | ONF |
| Date Received | 2014-07-15 |
| Model Number | STRATAPULSE |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | KN |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHANGHAI APOLO MEDICAL TECH CO LTD |
| Manufacturer Address | 3F, BLDG A, NO 388, YINDU RD XUHUI DISTRICT, SHANGHAI 200231 CH 200231 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-07-15 |