Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
lubricant, patient
Product Code
KMJ
Regulation Number
880.6375
Device Class
1
Premarket Reviews
Manufacturer
Decision
DUKAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
DYNAREX CORPORATION
SUBSTANTIALLY EQUIVALENT
1
JIANERKANG MEDICAL DRESSING COMPANY
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
NURSE ASSIST, INC.
SUBSTANTIALLY EQUIVALENT
1
PEDIATRIC PHARMACEUTICALS INC.
SUBSTANTIALLY EQUIVALENT
1
PEDIATRIC PHARMACEUTICALS, INC.
SUBSTANTIALLY EQUIVALENT
1
SION BIOTEXT MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
ULTRA SEAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
4
4
2016
5
5
2017
1
1
2018
5
5
2019
2
2
2020
1
1
2022
4
4
2023
4
4
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Patient-Device Incompatibility
4
4
Device Contamination with Chemical or Other Material
2
2
Use of Device Problem
1
1
Product Quality Problem
1
1
Device Markings/Labelling Problem
1
1
Microbial Contamination of Device
1
1
Contamination /Decontamination Problem
1
1
Difficult to Open or Close
1
1
Clumping in Device or Device Ingredient
1
1
Appropriate Term/Code Not Available
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Urinary Tract Infection
5
5
Burning Sensation
5
5
Hypersensitivity/Allergic reaction
4
4
No Known Impact Or Consequence To Patient
4
4
Granuloma
2
2
Unspecified Infection
2
2
Itching Sensation
2
2
Foreign Body Reaction
2
2
Swelling
2
2
Angioedema
1
1
Low Oxygen Saturation
1
1
Low Blood Pressure/ Hypotension
1
1
Sore Throat
1
1
No Consequences Or Impact To Patient
1
1
Bacterial Infection
1
1
Caustic/Chemical Burns
1
1
Shaking/Tremors
1
1
Tachycardia
1
1
Reaction
1
1
Pain
1
1
Laceration(s)
1
1
Dyspnea
1
1
Erythema
1
1
Discomfort
1
1
Depression
1
1
Rash
1
1
Foreign Body In Patient
1
1
Skin Erosion
1
1
Vaginal Mucosa Damage
1
1
Cardiac Arrest
1
1
Blister
1
1
Anaphylactoid
1
1
Dizziness
1
1
No Information
1
1
Abnormal Vaginal Discharge
1
1
Adult Respiratory Distress Syndrome
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Respiratory Distress
1
1
Nausea
1
1
Brain Injury
1
1
Syncope
1
1
Superficial (First Degree) Burn
1
1
Impaired Healing
1
1
Patient Problem/Medical Problem
1
1
Urticaria
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Amerx Health Care Corp.
II
Jul-20-2016
2
Apogee Medical
II
Feb-03-2011
3
Cardinal Health
II
Apr-13-2011
4
DeRoyal Processing Center
II
Apr-18-2011
5
Eli Lilly and Company
II
May-12-2011
6
H & P Industries, Inc. dba Triad Group
II
Jan-21-2011
7
MEDLINE IND
II
Jan-10-2017
8
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
9
Teleflex Medical
II
Apr-05-2011
10
Westone Laboratories, Inc.
II
Jul-20-2012
-
-