• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 Frayed 3 3
Material Disintegration 3 3
Device Contaminated During Manufacture or Shipping 2 2
Break 2 2
Insufficient Information 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Dislodged or Dislocated 2 2
Entrapment of Device 1 1
Incomplete or Missing Packaging 1 1
Patient-Device Incompatibility 1 1
Defective Component 1 1
Contamination 1 1
Delivered as Unsterile Product 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Nonstandard Device 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
Burn(s) 4 4
No Consequences Or Impact To Patient 4 4
Abrasion 3 3
Laceration(s) 3 3
Not Applicable 2 2
Discomfort 2 2
Contact Dermatitis 2 2
Unspecified Infection 1 1
Fungal Infection 1 1
Abnormal Vaginal Discharge 1 1
Blister 1 1
Erythema 1 1
Insufficient Information 1 1
Pain 1 1
Swelling/ Edema 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 Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
8 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
9 Medline Industries Inc II Mar-20-2020
-
-