| Device Type ID | 1712 |
| Device Name | Pouch, Colostomy |
| 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 | EZQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1712 |
| Device | Pouch, Colostomy |
| Product Code | EZQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ostomy Pouch And Accessories. |
| CFR Regulation Number | 876.5900 [🔎] |
| Device Problems | |
|---|---|
Malposition Of Device | 338 |
Adverse Event Without Identified Device Or Use Problem | 263 |
Difficult To Remove | 63 |
Human-Device Interface Problem | 55 |
Defective Device | 11 |
Leak / Splash | 11 |
Material Too Rigid Or Stiff | 10 |
Device Operates Differently Than Expected | 10 |
Product Quality Problem | 10 |
Sticking | 9 |
Device Markings / Labelling Problem | 5 |
Failure To Adhere Or Bond | 5 |
Increased Sensitivity | 4 |
Material Disintegration | 3 |
Incomplete Or Missing Packaging | 3 |
Device Handling Problem | 3 |
Device Contamination With Chemical Or Other Material | 2 |
Material Deformation | 2 |
Scratched Material | 2 |
Packaging Problem | 2 |
Fluid Leak | 2 |
Inflation Problem | 2 |
Activation Failure Including Expansion Failures | 2 |
Delamination | 2 |
Appropriate Term/Code Not Available | 2 |
Loss Of Or Failure To Bond | 1 |
Deflation Problem | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Misassembled | 1 |
Occlusion Within Device | 1 |
Defective Component | 1 |
Nonstandard Device | 1 |
Insufficient Information | 1 |
Crack | 1 |
Material Rupture | 1 |
Dull, Blunt | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Off-Label Use | 1 |
| Total Device Problems | 836 |