MAUDE report
MAUDE report 13958: HEYER-SCHULTE GEL BREAST IMPLANT, 225 CC
No Answer Provided · received Jun 13, 1994 · V. MUELLER DIV. BAXTER HEALTHCARE CORP.
Key facts
| MDR report key | 13958 |
|---|---|
| Report number | MW1002453 |
| Event type | No Answer Provided |
| Brand name | HEYER-SCHULTE GEL BREAST IMPLANT, 225 CC |
| Model number | STYLE 7000 ROUND |
| Catalog number | 350-7225 |
| Manufacturer | V. MUELLER DIV. BAXTER HEALTHCARE CORP. |
| Product code | FTR |
| Device class | Class III |
| Date received by FDA | Jun 13, 1994 |
| Report date | Jun 7, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 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: