Table 2.
Adverse event characterization | Genitourinary adverse events, n (%) |
---|---|
Injury type (n = 39) | |
Injuries | 32 (82) |
Device malfunction | 6 (15) |
Device not maintained | 1 (3) |
Injury location (n = 33) | |
Vagina/vulva | 22 (67) |
Urethra | 2 (6) |
Eye | 1 (3) |
Unknown | 5 (15) |
Other extremity, misfire | 3 (9) |
Report reason (n = 39) | |
Medical treatment | 16 (41) |
Device failure | 13 (33) |
Improper technique | 3 (8) |
Emotional stress | 2 (5) |
Financial burden | 2 (5) |
Unknown | 3 (8) |
Reporter type (n = 39) | |
Distributor | 6 (15) |
Voluntary (patient or provider) | 17 (44) |
Manufacturer | 16 (41) |