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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lubricant, personal
Definition This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
Product CodeNUC
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
ANSELL HEALTHCARE PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
ANSELL HEALTHCARE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
BATH CONCEPT COSMETICS (DONGGUAN) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BIO-TECH LUBRICANTS LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOFILM INC
  SUBSTANTIALLY EQUIVALENT 1
BIOFILM INC.
  SUBSTANTIALLY EQUIVALENT 7
BIOFILM, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOTECH LUBRICANTS LTD
  SUBSTANTIALLY EQUIVALENT 1
BOYA BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARRASHIELD LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CC WELLNESS LLC
  SUBSTANTIALLY EQUIVALENT 10
CEWAL, INC. DBA PREMIERE ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
CHURCH & DWIGHT CO., INC
  SUBSTANTIALLY EQUIVALENT 2
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 6
COCONU, LLC.
  SUBSTANTIALLY EQUIVALENT 1
COMBE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
CURVES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DESERT HARVEST, INC
  SUBSTANTIALLY EQUIVALENT 1
DR. AUGUST WOLFF GMBH & CO. KG ARZEIMITTEL
  SUBSTANTIALLY EQUIVALENT 1
DR. AUGUST WOLFF GMBH & CO. KG ARZNEIMITTEL
  SUBSTANTIALLY EQUIVALENT 1
DREAMBRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMPOWERED PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FAIRHAVEN HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
FARMA-DERMA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
FEMMEPHARMA CONSUMER HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FIDIA FARMACEUTICI S.P.A
  SUBSTANTIALLY EQUIVALENT 1
FIDIA FARMACEUTICI SPA
  SUBSTANTIALLY EQUIVALENT 2
FOSHAN PINGCHUANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GOOD CLEAN LOVE
  SUBSTANTIALLY EQUIVALENT 1
GOOD CLEAN LOVE, INC.
  SUBSTANTIALLY EQUIVALENT 5
GRAFENBERG LABS
  SUBSTANTIALLY EQUIVALENT 1
GUY & O'NEILL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ICM PHARMA PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
IMQUEST BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVEMED BIO-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON CONSUMER & PERSONAL PRODUCTS WOR
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON HEALTHCARE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
KAREX INDUSTRIES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LACLEDE, INC.
  SUBSTANTIALLY EQUIVALENT 2
LFBEAUTY (THAILAND) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LIL DRUG STORE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LOVE ALCHEMY LLC
  SUBSTANTIALLY EQUIVALENT 1
MANO AND MANO PROPRIETARY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MAYER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MD LABS LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NANTONG HEALTH & BEYOND HYGIENIC PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
NATUREPLEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
NECESSAIRE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEO COSMETIQUE
  SUBSTANTIALLY EQUIVALENT 1
NON-FRICTION PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
ONE
  SUBSTANTIALLY EQUIVALENT 2
PACKAGE SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
PEPTONIC MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
PERRIGO NEW YORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHARMAPAC LLC
  SUBSTANTIALLY EQUIVALENT 1
PJUR GROUP LUXEMBOURG SA
  SUBSTANTIALLY EQUIVALENT 5
PJUR GROUP,LUXEMBOURG S.A.
  SUBSTANTIALLY EQUIVALENT 1
PLAYGROUND FOR ALL
  SUBSTANTIALLY EQUIVALENT 1
POLICHEM S.A.
  SUBSTANTIALLY EQUIVALENT 2
R&R MEDICAL CORPORATION LTD
  SUBSTANTIALLY EQUIVALENT 1
RB HEALTH (US)
  SUBSTANTIALLY EQUIVALENT 1
RB HEALTH (US) LLC
  SUBSTANTIALLY EQUIVALENT 8
RECKITT BENCKISER
  SUBSTANTIALLY EQUIVALENT 1
RECKITT BENCKISER LLC
  SUBSTANTIALLY EQUIVALENT 3
RECKITT BENCKISER, LLC
  SUBSTANTIALLY EQUIVALENT 2
REOXCYN, LLC
  SUBSTANTIALLY EQUIVALENT 1
SASMAR INC
  SUBSTANTIALLY EQUIVALENT 1
SELECT LABS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEVEN OAKS RANCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUANQIU XUEBAO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMPLY SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOLEVY CO. LLC
  SUBSTANTIALLY EQUIVALENT 2
SURETEX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SXWELL USA LLC
  SUBSTANTIALLY EQUIVALENT 1
THAI NIPPON RUBBER INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED.
  SUBSTANTIALLY EQUIVALENT 1
THE BLOOMI INC..
  SUBSTANTIALLY EQUIVALENT 2
THE KAMA SUTRA COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TOASTER LABS, INC
  SUBSTANTIALLY EQUIVALENT 2
TOPCO SALES
  SUBSTANTIALLY EQUIVALENT 1
TORO MANAGEMENT LLC DBA SYLK
  SUBSTANTIALLY EQUIVALENT 1
TRIGG LABORATORIES D/B/A WET INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
TRIGG LABORATORIES DBA WET INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
TRIGG LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRIGG LABORATORIES, INC. D/B/A WET INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
TROPHIKOS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
  SUBSTANTIALLY EQUIVALENT 1
TYROS BIOPHARMA INC.
  SUBSTANTIALLY EQUIVALENT 1
UBERLUBE LLC
  SUBSTANTIALLY EQUIVALENT 1
UNIDERM FARMACEUTICI SRL
  SUBSTANTIALLY EQUIVALENT 2
UNITED CONSORTIUM
  SUBSTANTIALLY EQUIVALENT 13
UNITED CONSORTIUM INC.
  SUBSTANTIALLY EQUIVALENT 1
VALENCIA NATURALS INC.
  SUBSTANTIALLY EQUIVALENT 1
VALENCIA NATURALS, INC
  SUBSTANTIALLY EQUIVALENT 1
VIRAMAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
VJUVENATE, LLC
  SUBSTANTIALLY EQUIVALENT 1
WESTRIDGE LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WETTRUST KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WISCONSIN PHARMACAL CO., LLC
  SUBSTANTIALLY EQUIVALENT 1
WOO ESSENTIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WSM INVESTMENT LLC, DBA TOPCO SALES
  SUBSTANTIALLY EQUIVALENT 1
WTFN-DBA CLASSIC EROTICA/HOLIDAY PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
XR LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 14 14
2015 8 8
2016 14 14
2017 19 19
2018 6 6
2019 8 8
2020 2 2
2021 7 7
2022 7 7
2023 15 15
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 30 30
Insufficient Information 19 19
Patient-Device Incompatibility 17 17
Device Operates Differently Than Expected 5 5
Patient Device Interaction Problem 3 3
Unexpected Therapeutic Results 2 2
Packaging Problem 2 2
Cross Reactivity 2 2
Device Expiration Issue 2 2
Nonstandard Device 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Material Integrity Problem 1 1
No Fail-Safe Mechanism 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 28 28
Pain 19 19
Hypersensitivity/Allergic reaction 13 13
Urinary Tract Infection 12 12
Itching Sensation 9 9
Discomfort 9 9
No Code Available 8 8
Unspecified Infection 8 8
Hemorrhage/Bleeding 7 7
Rash 7 7
Irritation 6 6
Erythema 6 6
Fever 5 5
Skin Irritation 5 5
Abnormal Vaginal Discharge 5 5
Reaction 5 5
Caustic/Chemical Burns 4 4
Dysuria 4 4
Skin Inflammation/ Irritation 4 4
Swelling/ Edema 4 4
Insufficient Information 4 4
Swelling 4 4
Inflammation 4 4
Local Reaction 3 3
Vaginal Mucosa Damage 3 3
Skin Burning Sensation 3 3
No Known Impact Or Consequence To Patient 3 3
Skin Inflammation 3 3
Urinary Frequency 3 3
Complaint, Ill-Defined 2 2
Abdominal Cramps 2 2
Blister 2 2
Chills 2 2
Miscarriage 2 2
Abdominal Pain 2 2
Bacterial Infection 2 2
Burn(s) 2 2
Diarrhea 1 1
Dyspnea 1 1
Edema 1 1
Flatus 1 1
Micturition Urgency 1 1
High Blood Pressure/ Hypertension 1 1
Laceration(s) 1 1
Nausea 1 1
Discharge 1 1
Blurred Vision 1 1
Vomiting 1 1
Skin Discoloration 1 1
Skin Erosion 1 1
Swollen Glands 1 1
Thrombus 1 1
Urinary Retention 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Ambulation Difficulties 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
Localized Skin Lesion 1 1
Kidney Infection 1 1
Urticaria 1 1
Skin Tears 1 1
Fungal Infection 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1
Patient Problem/Medical Problem 1 1
Hematuria 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
2 INGfertility, LLC II Jan-23-2009
3 Mc-NEIL-PPC, Inc. II Feb-22-2013
4 Mc-NEIL-PPC, Inc. II Sep-27-2012
5 Memphis Fertility Laboratory Inc II Aug-27-2009
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