MAUDE report
MAUDE report 4382: AMS 800 GU SPHINCTER PROSTHESIS
Malfunction · received Oct 26, 1992 · AMERICAN MEDICAL SYSTEMS - PFIZER HOSPITAL PRODUCTS GROUP
Key facts
| MDR report key | 4382 |
|---|---|
| Report number | 4382 |
| Event type | Malfunction |
| Brand name | AMS 800 GU SPHINCTER PROSTHESIS |
| Model number | 800 GU |
| Manufacturer | AMERICAN MEDICAL SYSTEMS - PFIZER HOSPITAL PRODUCTS GROUP |
| Product code | FAG |
| Device class | Class III |
| Date received by FDA | Oct 26, 1992 |
| Report date | Oct 26, 1992 |
| Report source | Maude |
At a glance
- None Device problems coded
- 10–99 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: