| Device Type ID | 1677 |
| Device Name | Protector, Ostomy |
| Regulation Description | Ostomy Pouch And Accessories. |
| 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) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5900 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EXE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1677 |
| Device | Protector, Ostomy |
| Product Code | EXE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ostomy Pouch And Accessories. |
| CFR Regulation Number | 876.5900 [🔎] |
| Device Problems | |
|---|---|
Malposition Of Device | 3470 |
Adverse Event Without Identified Device Or Use Problem | 1037 |
Human-Device Interface Problem | 290 |
Difficult To Remove | 145 |
Increased Sensitivity | 51 |
Device Operates Differently Than Expected | 36 |
Material Disintegration | 35 |
Leak / Splash | 25 |
Sticking | 19 |
Failure To Adhere Or Bond | 14 |
Material Separation | 13 |
Material Too Rigid Or Stiff | 10 |
Defective Device | 9 |
Material Fragmentation | 8 |
Device Handling Problem | 6 |
Insufficient Information | 6 |
Device Abrasion From Instrument Or Another Object | 6 |
Appropriate Term/Code Not Available | 6 |
Delamination | 4 |
Material Discolored | 4 |
Material Integrity Problem | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Material Deformation | 4 |
Inadequacy Of Device Shape And/or Size | 3 |
Missing Value Reason | 3 |
Fluid Leak | 3 |
Wrinkled | 3 |
Melted | 3 |
Use Of Device Problem | 2 |
Patient-Device Incompatibility | 2 |
Flare Or Flash | 2 |
Difficult To Position | 2 |
Expulsion | 2 |
Off-Label Use | 1 |
Incomplete Or Missing Packaging | 1 |
Device Issue | 1 |
Partial Blockage | 1 |
Reflux Within Device | 1 |
Device Markings / Labelling Problem | 1 |
Improper Chemical Reaction | 1 |
Scratched Material | 1 |
Moisture Damage | 1 |
Compatibility Problem | 1 |
Product Quality Problem | 1 |
Unable To Confirm Conditions Of Use | 1 |
Gas Leak | 1 |
Deformation Due To Compressive Stress | 1 |
Loss Of Or Failure To Bond | 1 |
Degraded | 1 |
Material Frayed | 1 |
Occlusion Within Device | 1 |
| Total Device Problems | 5249 |