The link that you had supplied is from the MAUDE data base. Reports to the MAUDE data base are not voluntary. To search an adverse events data base that is
mandatory, search the MDR files.
The
MDR data base files for the medical devices lists the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury
during the years 1984 through 1996. After 31 Jul 1996 adverse events reporting became voluntary.The
MAUDE DATA BASE lists adverse events > 31 Jul 1996