• 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
2017 6 6
2018 2 2
2019 1 1
2020 9 9
2021 88 88
2022 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 106 106
Contamination /Decontamination Problem 9 9
Material Puncture/Hole 7 7
Detachment Of Device Component 3 3
Material Disintegration 3 3
Insufficient Information 2 2
Detachment of Device or Device Component 2 2
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
Loss of or Failure to Bond 1 1
Break 1 1
Material Separation 1 1
Defective Component 1 1
Incomplete or Missing Packaging 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Entrapment of Device 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 65 65
No Known Impact Or Consequence To Patient 14 14
Reaction 12 12
No Clinical Signs, Symptoms or Conditions 12 12
Rash 9 9
No Consequences Or Impact To Patient 5 5
Skin Inflammation/ Irritation 5 5
Abrasion 4 4
Burn(s) 4 4
Foreign Body In Patient 3 3
Contact Dermatitis 2 2
Laceration(s) 2 2
Discomfort 2 2
Device Embedded In Tissue or Plaque 2 2
Not Applicable 2 2
No Information 1 1
Blister 1 1
Abnormal Vaginal Discharge 1 1
Pain 1 1
Unspecified Infection 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
Hyperemia 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Fungal Infection 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
-
-