Table 1.
Adverse event characterization | Genitourinary adverse events, n (%) | Other aesthetic use adverse events, n (%) | Total, n |
---|---|---|---|
Adverse events, No. | 39 (33) | 79 (67) | 118 |
Manufacturers with adverse events | 6 (33) | 12 (67) | 18 |
Adverse event type | |||
Injury | 32 (44) | 63 (66) | 95 |
Malfunction | 6 (40) | 9 (60) | 15 |
Other | 1 (15) | 6 (85) | 7 |
Reporter type | |||
Manufacturer | 16 (17) | 80 (83) | 96 |
Distributor | 6 (100) | 0 | 6 |
Voluntary | 17 (100) | 0 | 17 |