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TPLC
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show TPLC since
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2024
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Device
pad, menstrual, unscented
Product Code
HHD
Regulation Number
884.5435
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
6
6
2016
4
4
2017
4
4
2018
5
5
2019
5
5
2020
2
2
2021
5
5
2022
8
8
2023
16
16
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient-Device Incompatibility
16
16
Device Emits Odor
15
15
Adverse Event Without Identified Device or Use Problem
10
10
Insufficient Information
6
6
Device Contaminated During Manufacture or Shipping
3
3
Patient Device Interaction Problem
3
3
Device Markings/Labelling Problem
3
3
Material Fragmentation
2
2
Material Separation
2
2
Product Quality Problem
2
2
Failure to Advance
1
1
Nonstandard Device
1
1
Physical Resistance/Sticking
1
1
Contamination /Decontamination Problem
1
1
Unraveled Material
1
1
Use of Device Problem
1
1
Sharp Edges
1
1
Packaging Problem
1
1
Bent
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Itching Sensation
20
20
Skin Inflammation/ Irritation
15
15
Rash
14
14
Hypersensitivity/Allergic reaction
12
12
Pain
10
10
Burning Sensation
9
9
Nausea
8
8
Erythema
7
7
Urinary Tract Infection
5
5
No Clinical Signs, Symptoms or Conditions
5
5
Caustic/Chemical Burns
5
5
Unspecified Infection
4
4
Sleep Dysfunction
3
3
Inflammation
3
3
Urinary Frequency
3
3
No Known Impact Or Consequence To Patient
3
3
Swelling
3
3
Ambulation Difficulties
2
2
Hematuria
2
2
Bacterial Infection
2
2
Aspiration/Inhalation
2
2
Local Reaction
2
2
Skin Discoloration
2
2
Swelling/ Edema
2
2
Unspecified Kidney or Urinary Problem
2
2
Peeling
2
2
Vomiting
2
2
Device Embedded In Tissue or Plaque
1
1
Full thickness (Third Degree) Burn
1
1
Cancer
1
1
Hemorrhage/Bleeding
1
1
Unspecified Tissue Injury
1
1
Toxic Shock Syndrome
1
1
Pneumonia
1
1
Reaction
1
1
Dyspnea
1
1
Scar Tissue
1
1
Discomfort
1
1
Insufficient Information
1
1
Skin Inflammation
1
1
Numbness
1
1
Irritation
1
1
Injury
1
1
Weakness
1
1
Cellulitis
1
1
Incontinence
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Reaction to Medicinal Component of Device
1
1
Anaphylactoid
1
1
Cyst(s)
1
1
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