| Device Type ID | 5757 |
| Device Name | Dressing, Wound, Hydrophilic |
| Regulation Description | Hydrophilic Wound Dressing. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4018 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NAC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5757 |
| Device | Dressing, Wound, Hydrophilic |
| Product Code | NAC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hydrophilic Wound Dressing. |
| CFR Regulation Number | 878.4018 [🔎] |
| Device Problems | |
|---|---|
Delivered As Unsterile Product | 236 |
Device Contamination With Chemical Or Other Material | 218 |
Adverse Event Without Identified Device Or Use Problem | 80 |
Failure To Adhere Or Bond | 75 |
Unsealed Device Packaging | 43 |
Difficult To Remove | 41 |
Increased Sensitivity | 25 |
Improper Or Incorrect Procedure Or Method | 16 |
Expiration Date Error | 16 |
Material Integrity Problem | 13 |
Device Operates Differently Than Expected | 11 |
Material Fragmentation | 10 |
Sticking | 10 |
Torn Material | 10 |
Leak / Splash | 9 |
Product Quality Problem | 9 |
Human-Device Interface Problem | 8 |
Device Packaging Compromised | 8 |
Shelf Life Exceeded | 5 |
Packaging Problem | 5 |
Material Disintegration | 5 |
Appropriate Term/Code Not Available | 5 |
Deformation Due To Compressive Stress | 4 |
Loss Of Or Failure To Bond | 4 |
Use Of Device Problem | 4 |
Defective Device | 4 |
Break | 3 |
Material Frayed | 3 |
Device Abrasion From Instrument Or Another Object | 2 |
Difficult To Open Or Remove Packaging Material | 2 |
Insufficient Information | 2 |
Free Or Unrestricted Flow | 2 |
Device Handling Problem | 2 |
Patient Device Interaction Problem | 1 |
Hole In Material | 1 |
Material Separation | 1 |
Incomplete Or Missing Packaging | 1 |
Material Deformation | 1 |
Adhesive | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Material Distortion | 1 |
Moisture Or Humidity Problem | 1 |
Fiber | 1 |
Entrapment Of Device | 1 |
Material Rupture | 1 |
Device Damaged Prior To Use | 1 |
Mechanical Problem | 1 |
Device Slipped | 1 |
Split | 1 |
Shipping Damage Or Problem | 1 |
Suction Problem | 1 |
Component Missing | 1 |
Physical Property Issue | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Device Difficult To Program Or Calibrate | 1 |
Contamination During Use | 1 |
| Total Device Problems | 913 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Amd-Ritmed, Inc. | II | Dec-08-2016 |