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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
Regulation Description Manual surgical instrument for general use.
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
2016 2 2
2017 6 6
2018 2 2
2019 1 1
2020 9 9
2021 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 41 41
Material Puncture/Hole 7 7
Contamination /Decontamination Problem 5 5
Detachment Of Device Component 4 4
Material Disintegration 3 3
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Component Falling 2 2
Break 2 2
Insufficient Information 2 2
Loss of or Failure to Bond 1 1
Defective Component 1 1
Incomplete or Missing Packaging 1 1
Structural Problem 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Entrapment of Device 1 1
Nonstandard Device 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 21 21
No Known Impact Or Consequence To Patient 14 14
Reaction 12 12
No Clinical Signs, Symptoms or Conditions 9 9
No Consequences Or Impact To Patient 5 5
Rash 4 4
Foreign Body In Patient 3 3
Not Applicable 2 2
Device Embedded In Tissue or Plaque 2 2
Pain 1 1
Discomfort 1 1
Fungal Infection 1 1
Insufficient Information 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Abrasion 1 1
Abnormal Vaginal Discharge 1 1
Contact Dermatitis 1 1
Laceration(s) 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 Inc II Mar-20-2020
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