MAUDE report
MAUDE report 12576: SURGITEK SCL GEL LO BLEED SILICONE GEL BREAST IMPLANT
No Answer Provided · received Apr 5, 1994 · MEDICAL ENGINEERING CORP.
Key facts
| MDR report key | 12576 |
|---|---|
| Report number | MW1001467 |
| Event type | No Answer Provided |
| Brand name | SURGITEK SCL GEL LO BLEED SILICONE GEL BREAST IMPLANT |
| Catalog number | 1490600, 1490800 |
| Manufacturer | MEDICAL ENGINEERING CORP. |
| Product code | FTR |
| Device class | Class III |
| Date received by FDA | Apr 5, 1994 |
| Report date | Mar 25, 1994 |
| 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
- No Adverse event flagged
- 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: