| Device Type ID | 5926 |
| Device Name | Expander, Skin, Inflatable |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LCJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5926 |
| Device | Expander, Skin, Inflatable |
| Product Code | LCJ |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALLERGAN | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ALLERGAN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MARZ MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECIALTY SURGICAL PRODUCTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECIALTY SURGICAL PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRADIS HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Rupture | 222 |
Fluid Leak | 219 |
Adverse Event Without Identified Device Or Use Problem | 124 |
No Apparent Adverse Event | 47 |
Break | 33 |
Improper Or Incorrect Procedure Or Method | 16 |
Patient-Device Incompatibility | 14 |
Device Contamination With Chemical Or Other Material | 13 |
Insufficient Information | 11 |
Appropriate Term/Code Not Available | 10 |
Use Of Device Problem | 8 |
Inflation Problem | 8 |
Leak / Splash | 7 |
Off-Label Use | 5 |
Migration Or Expulsion Of Device | 5 |
Delivered As Unsterile Product | 5 |
Connection Problem | 4 |
Deflation Problem | 4 |
Shipping Damage Or Problem | 4 |
Biofilm Coating In Device | 2 |
Unsealed Device Packaging | 2 |
Device Damaged Prior To Use | 2 |
Malposition Of Device | 2 |
Expander | 2 |
Flaked | 1 |
Device Markings / Labelling Problem | 1 |
Free Or Unrestricted Flow | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Device Expiration Issue | 1 |
Material Perforation | 1 |
Defective Device | 1 |
Incomplete Or Missing Packaging | 1 |
Device Packaging Compromised | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Material Deformation | 1 |
Component Missing | 1 |
Loss Of Or Failure To Bond | 1 |
Gas Leak | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 784 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Allergan Inc | II | Jul-18-2015 |
| 2 | Mentor Texas, LP. | II | Sep-10-2016 |
| 3 | Mentor Texas, LP. | II | Sep-07-2016 |