| Device Type ID | 5468 |
| Device Name | Tape And Bandage, Adhesive |
| Regulation Description | Medical Adhesive Tape And Adhesive Bandage. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5240 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KGX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5468 |
| Device | Tape And Bandage, Adhesive |
| Product Code | KGX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Medical Adhesive Tape And Adhesive Bandage. |
| CFR Regulation Number | 880.5240 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 409 |
Appropriate Term/Code Not Available | 51 |
Failure To Adhere Or Bond | 45 |
Insufficient Information | 42 |
Failure To Obtain Sample | 27 |
Mechanical Problem | 16 |
Loss Of Or Failure To Bond | 13 |
Device Slipped | 9 |
Defective Device | 9 |
Improper Or Incorrect Procedure Or Method | 8 |
Defective Component | 7 |
Difficult To Remove | 7 |
Device Operates Differently Than Expected | 6 |
No Apparent Adverse Event | 6 |
Difficult To Open Or Remove Packaging Material | 6 |
Missing Value Reason | 5 |
Sticking | 5 |
Unsealed Device Packaging | 5 |
Device Dislodged Or Dislocated | 5 |
Use Of Device Problem | 4 |
Delivered As Unsterile Product | 4 |
Patient-Device Incompatibility | 4 |
Tear, Rip Or Hole In Device Packaging | 4 |
Device Packaging Compromised | 4 |
Fire | 3 |
Migration Or Expulsion Of Device | 3 |
Delamination | 3 |
Adhesive | 2 |
Physical Resistance / Sticking | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Unintended Movement | 1 |
Detachment Of Device Component | 1 |
Leak / Splash | 1 |
Off-Label Use | 1 |
Inadequate Or Insufficient Training | 1 |
Device Issue | 1 |
Stretched | 1 |
Packaging Problem | 1 |
Temperature Problem | 1 |
Break | 1 |
Disconnection | 1 |
Device Markings / Labelling Problem | 1 |
Moisture Or Humidity Problem | 1 |
Chemical Problem | 1 |
Human-Device Interface Problem | 1 |
Material Integrity Problem | 1 |
Migration | 1 |
Device Fell | 1 |
| Total Device Problems | 734 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ASO, LLC | II | Aug-25-2015 |
| 2 | Breg Inc | II | May-02-2017 |
| 3 | Owens & Minor Distribution, Inc. | II | Jan-30-2016 |
| 4 | Safe N Simple, LLC | II | Jun-15-2018 |
| 5 | Zipline Medical | II | Mar-02-2015 |