Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device garment, protective, for incontinence
Product CodeEYQ
Regulation Number 876.5920
Device Class 1

MDR Year MDR Reports MDR Events
2014 11 11
2015 11 11
2016 6 6
2017 8 8
2018 20 20
2019 28 28
2020 4 4
2021 5 5
2022 5 5
2023 8 8
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 39 39
Patient-Device Incompatibility 21 21
Insufficient Information 12 12
Material Disintegration 4 4
Break 3 3
Device Emits Odor 3 3
Product Quality Problem 3 3
Device Operates Differently Than Expected 3 3
Material Split, Cut or Torn 3 3
Torn Material 2 2
Appropriate Term/Code Not Available 2 2
Defective Component 2 2
Gel Leak 2 2
Material Separation 2 2
Failure To Service 1 1
Inadequacy of Device Shape and/or Size 1 1
Unraveled Material 1 1
Improper or Incorrect Procedure or Method 1 1
Leak/Splash 1 1
Clumping in Device or Device Ingredient 1 1
Component Falling 1 1
Microbial Contamination of Device 1 1
Device Appears to Trigger Rejection 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Incorrect Device Or Component Shipped 1 1
Contamination of Device Ingredient or Reagent 1 1
Physical Property Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Tract Infection 22 22
Pain 21 21
Rash 21 21
Itching Sensation 14 14
Skin Irritation 12 12
Unspecified Infection 11 11
Burning Sensation 10 10
Fever 9 9
Irritation 8 8
Sepsis 8 8
Discomfort 8 8
No Consequences Or Impact To Patient 5 5
Swelling 4 4
Injury 4 4
Abnormal Vaginal Discharge 4 4
Reaction 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Inflammation 4 4
Abscess 4 4
Bacterial Infection 3 3
Dyspnea 3 3
Erythema 3 3
Fall 3 3
Headache 3 3
Insufficient Information 3 3
Fungal Infection 3 3
Caustic/Chemical Burns 3 3
Scar Tissue 2 2
Blood Loss 2 2
No Known Impact Or Consequence To Patient 2 2
Partial thickness (Second Degree) Burn 2 2
Hypersensitivity/Allergic reaction 2 2
Nausea 2 2
Respiratory Distress 2 2
Local Reaction 2 2
Bone Fracture(s) 2 2
Fungus 2 2
Gangrene 2 2
Purulent Discharge 2 2
Anaphylactic Shock 2 2
Antibiotics, Reaction To 1 1
Asthma 1 1
Abrasion 1 1
Cyst(s) 1 1
Diarrhea 1 1
Foreign Body Reaction 1 1
Fatigue 1 1
Renal Failure 1 1
Staphylococcus Aureus 1 1
Incontinence 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Miscarriage 1 1
No Code Available 1 1
Pregnancy 1 1
Skin Disorders 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematuria 1 1
Chemical Exposure 1 1
Respiratory Failure 1 1
Numbness 1 1
Vomiting 1 1
Malaise 1 1
Joint Dislocation 1 1
Swollen Lymph Nodes 1 1
Skin Discoloration 1 1
Heart Failure 1 1
Urinary Frequency 1 1
Urticaria 1 1
Pressure Sores 1 1
Anxiety 1 1

-
-