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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
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 6
BOYA BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CC WELLNESS LLC
  SUBSTANTIALLY EQUIVALENT 10
CHURCH & DWIGHT CO., INC
  SUBSTANTIALLY EQUIVALENT 1
COCONU, LLC.
  SUBSTANTIALLY EQUIVALENT 1
DESERT HARVEST, INC
  SUBSTANTIALLY EQUIVALENT 1
DR. AUGUST WOLFF GMBH & CO. KG ARZNEIMITTEL
  SUBSTANTIALLY EQUIVALENT 1
DREAMBRANDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FAIRHAVEN HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
FARMA-DERMA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
FEMMEPHARMA CONSUMER HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FIDIA FARMACEUTICI S.P.A
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN PINGCHUANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GOOD CLEAN LOVE, INC.
  SUBSTANTIALLY EQUIVALENT 4
INNOVEMED BIO-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGXI WULINXIANG BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAREX INDUSTRIES SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1
LFBEAUTY (THAILAND) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MD LABS LLC
  SUBSTANTIALLY EQUIVALENT 1
NANTONG HEALTH & BEYOND HYGIENIC PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
PEPTONIC MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
PJUR GROUP LUXEMBOURG SA
  SUBSTANTIALLY EQUIVALENT 3
PLAYGROUND FOR ALL
  SUBSTANTIALLY EQUIVALENT 1
R&R MEDICAL CORPORATION LTD
  SUBSTANTIALLY EQUIVALENT 1
RB HEALTH (US)
  SUBSTANTIALLY EQUIVALENT 1
RB HEALTH (US) LLC
  SUBSTANTIALLY EQUIVALENT 8
REOXCYN, LLC
  SUBSTANTIALLY EQUIVALENT 1
SELECT LABS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUANQIU XUEBAO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLEVY CO. LLC
  SUBSTANTIALLY EQUIVALENT 2
SURETEX LIMITED
  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
TRIGG LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRIGG LABORATORIES, INC. D/B/A WET INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
TROPHIKOS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TYROS BIOPHARMA INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED CONSORTIUM
  SUBSTANTIALLY EQUIVALENT 5
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
WOO ESSENTIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XR LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 2 2
2021 7 7
2022 7 7
2023 15 15
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 13 13
Adverse Event Without Identified Device or Use Problem 11 11
Patient Device Interaction Problem 3 3
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Excessive Heating 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 10 10
Urinary Tract Infection 7 7
Pain 7 7
Hypersensitivity/Allergic reaction 6 6
Hemorrhage/Bleeding 4 4
Skin Inflammation/ Irritation 4 4
Itching Sensation 4 4
Erythema 4 4
Swelling/ Edema 4 4
Insufficient Information 4 4
Unspecified Infection 3 3
Skin Burning Sensation 3 3
Abnormal Vaginal Discharge 3 3
Local Reaction 3 3
Caustic/Chemical Burns 3 3
Rash 3 3
Discomfort 3 3
Inflammation 2 2
Blister 2 2
Fever 2 2
Kidney Infection 1 1
Ambulation Difficulties 1 1
Full thickness (Third Degree) Burn 1 1
Bacterial Infection 1 1
Urinary Frequency 1 1
Skin Tears 1 1
Blurred Vision 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Fluid Discharge 1 1
Laceration(s) 1 1
Vomiting 1 1
Swelling 1 1
Burn(s) 1 1
Irritation 1 1
Chills 1 1
Skin Discoloration 1 1
No Known Impact Or Consequence To Patient 1 1
Localized Skin Lesion 1 1
Abdominal Cramps 1 1
Dysuria 1 1
Fungal Infection 1 1
Skin Irritation 1 1
No Code Available 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
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