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TPLC
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show TPLC since
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Device
collector, ostomy
Product Code
EXB
Regulation Number
876.5900
Device Class
1
Premarket Reviews
Manufacturer
Decision
11 HEALTH TECHNOLOGIES LIMITED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
20
20
2018
36
36
2019
34
34
2020
22
22
2021
41
41
2022
24
24
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
108
108
Patient-Device Incompatibility
33
33
Malposition of Device
9
9
Insufficient Information
6
6
Biocompatibility
4
4
Failure To Adhere Or Bond
3
3
Leak/Splash
3
3
Inadequacy of Device Shape and/or Size
2
2
Device Operates Differently Than Expected
2
2
Loss of or Failure to Bond
2
2
Fluid Leak
2
2
Use of Device Problem
2
2
Defective Device
1
1
Inadequate User Interface
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Appropriate Term/Code Not Available
1
1
Device Disinfection Or Sterilization Issue
1
1
Patient Device Interaction Problem
1
1
Device Reprocessing Problem
1
1
Device Emits Odor
1
1
Material Integrity Problem
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Rash
34
34
Skin Inflammation/ Irritation
30
30
Skin Irritation
25
25
Erythema
19
19
Hypersensitivity/Allergic reaction
15
15
Itching Sensation
13
13
Urticaria
9
9
Unspecified Infection
9
9
No Consequences Or Impact To Patient
8
8
Skin Erosion
6
6
Skin Tears
5
5
Skin Infection
5
5
Tissue Damage
5
5
Abrasion
4
4
Fungal Infection
4
4
No Known Impact Or Consequence To Patient
4
4
Tissue Breakdown
3
3
Blister
3
3
Skin Inflammation
3
3
Inflammation
3
3
Swelling
2
2
Hemorrhage/Bleeding
2
2
Reaction
2
2
Blood Loss
2
2
No Patient Involvement
2
2
Laceration(s)
2
2
Fever
2
2
Insufficient Information
2
2
Contact Dermatitis
1
1
Pressure Sores
1
1
Pain
1
1
Burning Sensation
1
1
Anxiety
1
1
Depression
1
1
Impaired Healing
1
1
Exposure to Body Fluids
1
1
Urinary Tract Infection
1
1
Inadequate Pain Relief
1
1
Cellulitis
1
1
Death
1
1
Discharge
1
1
Wheal(s)
1
1
Irritation
1
1
Septic Shock
1
1
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