| Device Type ID | 5758 |
| Device Name | Dressing, Wound, Occlusive |
| Regulation Description | Occlusive 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 | 878.4020 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NAD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5758 |
| Device | Dressing, Wound, Occlusive |
| Product Code | NAD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Occlusive Wound Dressing. |
| CFR Regulation Number | 878.4020 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 857 |
Delivered As Unsterile Product | 466 |
Unsealed Device Packaging | 186 |
Adverse Event Without Identified Device Or Use Problem | 121 |
Difficult To Remove | 94 |
Failure To Adhere Or Bond | 80 |
Device Contaminated During Manufacture Or Shipping | 80 |
Use Of Device Problem | 50 |
Appropriate Term/Code Not Available | 26 |
Device Operates Differently Than Expected | 26 |
Difficult To Open Or Remove Packaging Material | 23 |
Insufficient Information | 21 |
Material Disintegration | 13 |
Suction Problem | 9 |
Packaging Problem | 8 |
Device Packaging Compromised | 8 |
Sticking | 7 |
Material Separation | 5 |
Device Expiration Issue | 5 |
Material Integrity Problem | 5 |
Tear, Rip Or Hole In Device Packaging | 4 |
Human-Device Interface Problem | 4 |
Defective Device | 4 |
Material Fragmentation | 4 |
Material Deformation | 4 |
Failure To Obtain Sample | 3 |
Patient-Device Incompatibility | 3 |
Product Quality Problem | 3 |
Loss Of Or Failure To Bond | 3 |
Melted | 2 |
Material Twisted / Bent | 2 |
Inadequate Filtration Process | 2 |
Device Handling Problem | 2 |
Patient Device Interaction Problem | 2 |
Off-Label Use | 1 |
Material Too Rigid Or Stiff | 1 |
Leak / Splash | 1 |
Mechanical Problem | 1 |
Shelf Life Exceeded | 1 |
Disconnection | 1 |
Material Rupture | 1 |
Device Damaged Prior To Use | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Wrinkled | 1 |
Absorber | 1 |
Increased Sensitivity | 1 |
Material Discolored | 1 |
Shipping Damage Or Problem | 1 |
Delamination | 1 |
No Apparent Adverse Event | 1 |
Material Frayed | 1 |
| Total Device Problems | 2149 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | COVIDIEN LLC | II | Oct-03-2018 |
| 2 | Coloplast Manufacturing US, LLC | III | Oct-24-2014 |
| 3 | Covidien LLC | II | Mar-27-2017 |