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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device skin prep tray
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Product CodeOJU
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 9 9
2021 88 88
2022 41 41
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 107 107
Contamination /Decontamination Problem 9 9
Material Puncture/Hole 7 7
Material Disintegration 3 3
Material Frayed 3 3
Insufficient Information 2 2
Device Dislodged or Dislocated 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Break 2 2
Contamination 1 1
Entrapment of Device 1 1
Material Separation 1 1
Defective Component 1 1
Incomplete or Missing Packaging 1 1
Patient-Device Incompatibility 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 65 65
No Clinical Signs, Symptoms or Conditions 16 16
Reaction 12 12
No Known Impact Or Consequence To Patient 11 11
Rash 9 9
Foreign Body In Patient 7 7
Skin Inflammation/ Irritation 5 5
No Consequences Or Impact To Patient 4 4
Burn(s) 4 4
Laceration(s) 3 3
Abrasion 3 3
Discomfort 2 2
Contact Dermatitis 2 2
Not Applicable 2 2
Blister 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Abnormal Vaginal Discharge 1 1
Fungal Infection 1 1
Pain 1 1
Unspecified Infection 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
Hyperemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Centurion Medical Products Corporation II Feb-05-2020
3 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
4 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
6 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
7 Medline Industries Inc II Mar-20-2020
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