Table 2.
Intraoperative |
Postoperative |
|||||
---|---|---|---|---|---|---|
AE type | Moderate | Severe | Moderate | Severe | Totals | Rate per 10,000 MCs |
Surgical | ||||||
Bleeding | 2 | 1 | 13 | 4 | 20 | 4.8 |
Infection | 0 | 0 | 57 | 10 | 67 | 16.2 |
Insufficient skin removal | 0 | 0 | 0 | 3 | 3 | 0.7 |
Other | 0 | 0 | 0 | 1 | 1 | 0.2 |
Pain | 0 | 1 | 0 | 0 | 1 | 0.2 |
Scarring, disfigurement, or damage to penis | 0 | 2 | 0 | 1 | 3 | 0.7 |
Swelling | 0 | 0 | 2 | 3 | 5 | 1.2 |
Wound disruption | 0 | 0 | 14 | 2 | 16 | 3.9 |
Subtotal | 2 | 4 | 86 | 24 | 116 | 28.0 |
PrePex | ||||||
Device displacement | - | - | 2 | 26 | 28 | 81.1 |
Infection | - | - | 7 | 0 | 7 | 20.3 |
Pain | - | - | 3 | 1 | 4 | 11.6 |
Swelling | - | - | 1 | 0 | 1 | 2.9 |
Subtotal | - | - | 13 | 27 | 40 | 115.9 |
Total AEs | 2 | 4 | 99 | 51 | 156 | 34.8 |