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TPLC
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show TPLC since
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2024
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Device
tampon, menstrual, scented, deodorized
Product Code
HIL
Regulation Number
884.5460
Device Class
2
Premarket Reviews
Manufacturer
Decision
ONTEX BVBA
SUBSTANTIALLY EQUIVALENT
1
PLAYTEX MANUFACTURING INC.
SUBSTANTIALLY EQUIVALENT
2
PLAYTEX, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
3
3
2016
4
4
2017
2
2
2018
1
1
2019
1
1
2020
12
12
2021
7
7
2022
2
2
2023
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
18
18
Adverse Event Without Identified Device or Use Problem
11
11
No Apparent Adverse Event
6
6
Material Separation
3
3
Patient-Device Incompatibility
2
2
Detachment of Device or Device Component
1
1
Device Operates Differently Than Expected
1
1
Compatibility Problem
1
1
Defective Component
1
1
Device Contamination with Body Fluid
1
1
Malposition of Device
1
1
Degraded
1
1
Entrapment of Device
1
1
Device Emits Odor
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Foreign Body In Patient
13
13
Toxic Shock Syndrome
9
9
Device Embedded In Tissue or Plaque
5
5
No Clinical Signs, Symptoms or Conditions
4
4
Discomfort
3
3
Vomiting
2
2
No Consequences Or Impact To Patient
2
2
Bacterial Infection
2
2
Fever
2
2
Unspecified Infection
2
2
Pain
2
2
Rash
2
2
Local Reaction
1
1
Sepsis
1
1
Itching Sensation
1
1
Menstrual Irregularities
1
1
Abdominal Pain
1
1
Abrasion
1
1
Hair Loss
1
1
Headache
1
1
Hypersensitivity/Allergic reaction
1
1
Deafness
1
1
Diarrhea
1
1
Erythema
1
1
Anxiety
1
1
Patient Problem/Medical Problem
1
1
No Known Impact Or Consequence To Patient
1
1
Skin Inflammation/ Irritation
1
1
Burning Sensation
1
1
Chills
1
1
Abnormal Vaginal Discharge
1
1
Loss of Vision
1
1
Injury
1
1
Malaise
1
1
Disability
1
1
Coma
1
1
Loss of consciousness
1
1
Confusion/ Disorientation
1
1
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