MAUDE report
MAUDE report 9160: CANDELA PULSED DYE LASER
No Answer Provided · received Jul 29, 1994 · CANDELA LASER
Key facts
| MDR report key | 9160 |
|---|---|
| Report number | 9160 |
| Event type | No Answer Provided |
| Brand name | CANDELA PULSED DYE LASER |
| Model number | SPTL-1 |
| Manufacturer | CANDELA LASER |
| Date received by FDA | Jul 29, 1994 |
| Report date | Jul 11, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- 1–9 Injury reports for this brand
- Yes 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: