| Device Type ID | 5936 |
| Device Name | Dressing, Wound And Burn, Interactive |
| 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 | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MGR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5936 |
| Device | Dressing, Wound And Burn, Interactive |
| Product Code | MGR |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7 |
Failure To Adhere Or Bond | 2 |
Microbial Contamination Of Device | 2 |
Device Expiration Issue | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 15 |