Table 1.

Characteristics of included reports.

Characteristics	Full cohort (n = 4,994)
Report source (n, %)
Voluntary report	482 (9.65)
User facility report	3 (0.06)
Manufacturer report	4,509 (90.29)
Reporter occupation (n, %), frequency missing = 341
Other	4,195 (90.16)
Physician	3 (0.06)
Non-healthcare professional	451 (9.69)
Risk manager	2 (0.04)
Unknown	2 (0.04)
Initial report to FDA (n, %), frequency missing = 342
Yes	38 (0.82)
No	4,038 (86.80)
Unknown	576 (12.38)
Event type (n, %)
Death	10 (0.20)
Injury	4,929 (98.7)
Malfunction	53 (1.06)
Other	2 (0.04)