MAUDE report
MAUDE report 58523: SPTL LASER SYSTEM
Other · received Dec 17, 1996 · CANDELA CORP.
Key facts
| MDR report key | 58523 |
|---|---|
| Report number | 1218402-1996-00035 |
| Event type | Other |
| Brand name | SPTL LASER SYSTEM |
| Model number | 9904-10-0410 |
| Catalog number | 9904-10-0410 |
| Manufacturer | CANDELA CORP. |
| Product code | GEX |
| Device class | Class II |
| Date received by FDA | Dec 17, 1996 |
| Report date | Dec 16, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- None Injury reports for this brand
- Yes Adverse event flagged
- No Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: