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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 AND TECHNOLOGIES LLC
SUBSTANTIALLY EQUIVALENT
1
1. K140938
OSTOM-I ALERT
11 HEALTH TECHNOLOGIES LIMITED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
55
55
2015
6
6
2016
20
20
2017
20
20
2018
36
36
2019
34
34
2020
22
22
2021
41
41
2022
36
36
2023
11
11
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
149
149
Patient-Device Incompatibility
36
36
Insufficient Information
33
33
Human-Device Interface Problem
10
10
Malposition of Device
9
9
Device Operates Differently Than Expected
9
9
Leak/Splash
7
7
Inadequacy of Device Shape and/or Size
5
5
Biocompatibility
4
4
Fluid/Blood Leak
4
4
Use of Device Problem
3
3
Failure To Adhere Or Bond
3
3
Loss of or Failure to Bond
3
3
No Flow
3
3
Loose or Intermittent Connection
2
2
Defective Device
2
2
Device Disinfection Or Sterilization Issue
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Occlusion Within Device
1
1
Device Emits Odor
1
1
Product Quality Problem
1
1
Material Separation
1
1
Device Reprocessing Problem
1
1
Partial Blockage
1
1
Appropriate Term/Code Not Available
1
1
Patient Device Interaction Problem
1
1
Inadequate User Interface
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Unintended Movement
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Rash
55
55
Skin Inflammation/ Irritation
44
44
Skin Irritation
38
38
Erythema
38
38
Itching Sensation
38
38
Hypersensitivity/Allergic reaction
22
22
Unspecified Infection
15
15
Skin Discoloration
10
10
Skin Erosion
9
9
Skin Infection
9
9
Urticaria
9
9
Reaction
8
8
Skin Inflammation
8
8
No Consequences Or Impact To Patient
8
8
Swelling
8
8
Tissue Damage
8
8
Skin Tears
7
7
Fungal Infection
7
7
No Known Impact Or Consequence To Patient
7
7
Hemorrhage/Bleeding
6
6
Abrasion
6
6
Irritation
5
5
Pain
5
5
Blister
5
5
Tissue Breakdown
5
5
Blood Loss
4
4
Burning Sensation
4
4
Inflammation
4
4
Discharge
3
3
Fluid Discharge
3
3
Ulcer
3
3
No Code Available
2
2
Contact Dermatitis
2
2
Insufficient Information
2
2
No Clinical Signs, Symptoms or Conditions
2
2
No Patient Involvement
2
2
Discomfort
2
2
Peeling
2
2
Fever
2
2
Laceration(s)
2
2
Abscess
2
2
Death
2
2
Emotional Changes
1
1
Wound Dehiscence
1
1
Abdominal Pain
1
1
Anemia
1
1
Bacterial Infection
1
1
Exposure to Body Fluids
1
1
Burn(s)
1
1
Cellulitis
1
1
Headache
1
1
Respiratory Distress
1
1
Septic Shock
1
1
Ulceration
1
1
Urinary Retention
1
1
Urinary Tract Infection
1
1
Hernia
1
1
Wheal(s)
1
1
Concussion
1
1
Injury
1
1
Depression
1
1
Impaired Healing
1
1
Inadequate Pain Relief
1
1
Pressure Sores
1
1
Anxiety
1
1
Sleep Dysfunction
1
1
Post Operative Wound Infection
1
1
No Information
1
1
Skin Burning Sensation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Coloplast Manufacturing US, LLC
II
Sep-09-2011
2
Convatec Inc.
III
Oct-05-2011
3
Convatec Inc.
III
Mar-08-2011
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