| Device Type ID | 1719 |
| Device Name | Prosthesis, Penile |
| Regulation Description | Penile Rigidity Implant. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.3630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FAE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1719 |
| Device | Prosthesis, Penile |
| Product Code | FAE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Penile Rigidity Implant. |
| CFR Regulation Number | 876.3630 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 172 |
Adverse Event Without Identified Device Or Use Problem | 111 |
Cylinder | 35 |
Inadequacy Of Device Shape And/or Size | 29 |
Mechanical Problem | 21 |
Device Operates Differently Than Expected | 20 |
Migration Or Expulsion Of Device | 15 |
Break | 6 |
Defective Device | 5 |
Extrusion | 5 |
Fracture | 4 |
Malposition Of Device | 4 |
Device Inoperable | 3 |
Migration | 3 |
Use Of Device Problem | 3 |
Noise, Audible | 2 |
Material Too Soft / Flexible | 1 |
Detachment Of Device Or Device Component | 1 |
Crack | 1 |
Positioning Problem | 1 |
Material Protrusion / Extrusion | 1 |
Deformation Due To Compressive Stress | 1 |
Device Dislodged Or Dislocated | 1 |
Degraded | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Extender | 1 |
Material Discolored | 1 |
Inflation Problem | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 451 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Coloplast Manufacturing US, LLC | II | Apr-27-2015 |