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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lubricant, patient
Product CodeKMJ
Regulation Number 880.6375
Device Class 1


Premarket Reviews
ManufacturerDecision
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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 8 8
Patient-Device Incompatibility 4 4
Device Contamination with Chemical or Other Material 2 2
Appropriate Term/Code Not Available 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1
Clumping in Device or Device Ingredient 1 1
Product Quality Problem 1 1
Use of Device Problem 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 5 5
Urinary Tract Infection 5 5
Hypersensitivity/Allergic reaction 4 4
No Known Impact Or Consequence To Patient 4 4
Swelling 2 2
Unspecified Infection 2 2
Itching Sensation 2 2
Laceration(s) 1 1
Nausea 1 1
Pain 1 1
Rash 1 1
Respiratory Distress 1 1
Skin Erosion 1 1
Syncope 1 1
Adult Respiratory Distress Syndrome 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Dyspnea 1 1
Erythema 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Dizziness 1 1
No Consequences Or Impact To Patient 1 1
Anaphylactoid 1 1
Brain Injury 1 1
Urticaria 1 1
Discomfort 1 1
Depression 1 1
Impaired Healing 1 1
Sore Throat 1 1
Reaction 1 1
Low Oxygen Saturation 1 1
Shaking/Tremors 1 1
Caustic/Chemical Burns 1 1
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Tachycardia 1 1
Low Blood Pressure/ Hypotension 1 1
No Information 1 1
Angioedema 1 1
Blister 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Abnormal Vaginal Discharge 1 1
Vaginal Mucosa Damage 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
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