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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lubricant, personal
Regulation Description Condom.
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 3
BIOFILM, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTECH LUBRICANTS LTD
  SUBSTANTIALLY EQUIVALENT 1
BOYA BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CC WELLNESS LLC
  SUBSTANTIALLY EQUIVALENT 6
CEWAL, INC. DBA PREMIERE ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
CHURCH & DWIGHT CO., INC
  SUBSTANTIALLY EQUIVALENT 2
COCONU, LLC.
  SUBSTANTIALLY EQUIVALENT 1
COMBE INCORPORATED
  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
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
  SUBSTANTIALLY EQUIVALENT 1
GOOD CLEAN LOVE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ICM PHARMA PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
IMQUEST BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
LACLEDE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LFBEAUTY (THAILAND) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LOVE ALCHEMY LLC
  SUBSTANTIALLY EQUIVALENT 1
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
PEPTONIC MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
PERRIGO NEW YORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
PJUR GROUP LUXEMBOURG SA
  SUBSTANTIALLY EQUIVALENT 3
RB HEALTH (US) LLC
  SUBSTANTIALLY EQUIVALENT 6
RECKITT BENCKISER LLC
  SUBSTANTIALLY EQUIVALENT 1
REOXCYN, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUANQIU XUEBAO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLEVY CO. LLC
  SUBSTANTIALLY EQUIVALENT 2
SXWELL USA LLC
  SUBSTANTIALLY EQUIVALENT 1
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TRIGG LABORATORIES DBA WET INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
TRIGG LABORATORIES, INC. D/B/A WET INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
TROPHIKOS, LLC
  SUBSTANTIALLY EQUIVALENT 1
UNITED CONSORTIUM
  SUBSTANTIALLY EQUIVALENT 12
VALENCIA NATURALS INC.
  SUBSTANTIALLY EQUIVALENT 1
VIRAMAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VJUVENATE, LLC
  SUBSTANTIALLY EQUIVALENT 1
WETTRUST KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WSM INVESTMENT LLC, DBA TOPCO SALES
  SUBSTANTIALLY EQUIVALENT 1
XR LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 19 19
2018 6 6
2019 8 8
2020 2 2
2021 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Patient-Device Incompatibility 9 9
Insufficient Information 8 8
Device Operates Differently Than Expected 2 2
Patient Device Interaction Problem 1 1
Packaging Problem 1 1
Contamination /Decontamination Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Cross Reactivity 1 1
Nonstandard Device 1 1
Difficult to Remove 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 17 17
Pain 8 8
Hypersensitivity/Allergic reaction 6 6
Unspecified Infection 5 5
Rash 5 5
Urinary Tract Infection 5 5
Skin Irritation 4 4
Discomfort 4 4
Itching Sensation 4 4
Dysuria 4 4
Hemorrhage/Bleeding 3 3
Irritation 3 3
Erythema 3 3
Abdominal Pain 2 2
Reaction 2 2
Urinary Frequency 2 2
Abnormal Vaginal Discharge 2 2
Vaginal Mucosa Damage 2 2
Skin Inflammation 2 2
No Known Impact Or Consequence To Patient 2 2
No Code Available 2 2
Blister 1 1
Skin Burning Sensation 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Hematuria 1 1
Patient Problem/Medical Problem 1 1
Blurred Vision 1 1
Swelling 1 1
Swollen Glands 1 1
Thrombus 1 1
Urinary Retention 1 1
Urticaria 1 1
Chills 1 1
Discharge 1 1
Fungal Infection 1 1
Complaint, Ill-Defined 1 1
Bacterial Infection 1 1
Burn(s) 1 1
Dyspnea 1 1
Edema 1 1
Fever 1 1
Micturition Urgency 1 1
Inflammation 1 1
Laceration(s) 1 1
Local Reaction 1 1
Skin Erosion 1 1

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