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TPLC
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show TPLC since
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2021
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2024
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Device
electrode, ph, stomach
Product Code
FFT
Regulation Number
876.1400
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
621
621
2020
770
770
2021
516
516
2022
260
260
2023
259
259
2024
54
54
Device Problems
MDRs with this Device Problem
Events in those MDRs
Positioning Failure
1430
1430
Loss of or Failure to Bond
644
644
Detachment of Device or Device Component
171
171
Failure to Transmit Record
103
103
Entrapment of Device
64
64
Separation Failure
51
51
Unintended Application Program Shut Down
46
46
Insufficient Information
44
44
Adverse Event Without Identified Device or Use Problem
34
34
Signal Artifact/Noise
18
18
Activation, Positioning or Separation Problem
16
16
Activation Problem
15
15
Break
13
13
Difficult or Delayed Separation
12
12
Loss of Data
11
11
Loss of Power
11
11
Failure to Power Up
8
8
Data Problem
8
8
Activation Failure
8
8
Material Twisted/Bent
6
6
Malposition of Device
5
5
Failure to Advance
5
5
High pH
5
5
Defective Device
4
4
Poor Quality Image
4
4
Calibration Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Premature Separation
4
4
Physical Resistance/Sticking
3
3
Low pH
3
3
Device Dislodged or Dislocated
3
3
Connection Problem
3
3
Failure to Calibrate
3
3
Use of Device Problem
3
3
Unexpected Shutdown
3
3
Difficult to Remove
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Device Alarm System
2
2
Device Slipped
2
2
Loose or Intermittent Connection
2
2
Mechanical Problem
2
2
Migration or Expulsion of Device
2
2
No Display/Image
2
2
Failure to Fire
2
2
Blocked Connection
2
2
Material Integrity Problem
2
2
Patient Device Interaction Problem
2
2
Migration
2
2
Noise, Audible
2
2
Separation Problem
2
2
Device Fell
1
1
Complete Loss of Power
1
1
Inaccurate Information
1
1
Key or Button Unresponsive/not Working
1
1
Wireless Communication Problem
1
1
Firing Problem
1
1
Mechanics Altered
1
1
Unintended Movement
1
1
Output Problem
1
1
Communication or Transmission Problem
1
1
Display or Visual Feedback Problem
1
1
Material Fragmentation
1
1
Crack
1
1
Premature Discharge of Battery
1
1
Nonstandard Device
1
1
Premature Activation
1
1
Unable to Obtain Readings
1
1
Failure to Align
1
1
Device Displays Incorrect Message
1
1
Misfire
1
1
Failure to Sense
1
1
Inadequacy of Device Shape and/or Size
1
1
Failure to Reset
1
1
Improper or Incorrect Procedure or Method
1
1
Suction Problem
1
1
Defective Component
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1030
1030
No Clinical Signs, Symptoms or Conditions
693
693
Foreign Body In Patient
270
270
Airway Obstruction
268
268
No Information
69
69
Insufficient Information
57
57
Aspiration/Inhalation
54
54
Injury
39
39
Chest Pain
37
37
No Known Impact Or Consequence To Patient
36
36
Pain
30
30
Laceration(s) of Esophagus
23
23
Unintended Radiation Exposure
23
23
Radiation Exposure, Unintended
22
22
No Code Available
17
17
Sedation
17
17
Oversedation
17
17
Hemorrhage/Bleeding
11
11
Cough
11
11
Discomfort
10
10
Failure of Implant
8
8
Unspecified Tissue Injury
8
8
Blood Loss
8
8
Sore Throat
7
7
Tissue Damage
6
6
Vomiting
6
6
Dysphagia/ Odynophagia
6
6
Dyspnea
5
5
Ulcer
4
4
Laceration(s)
4
4
Nausea
4
4
Inflammation
3
3
No Patient Involvement
3
3
Low Oxygen Saturation
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Hypoxia
2
2
Fever
2
2
Abdominal Pain
2
2
Pyrosis/Heartburn
2
2
Asthma
2
2
Bradycardia
1
1
Burn(s)
1
1
Cyanosis
1
1
Diarrhea
1
1
Awareness during Anaesthesia
1
1
Apnea
1
1
Low Blood Pressure/ Hypotension
1
1
Foreign Body Sensation in Eye
1
1
Perforation
1
1
Respiratory Distress
1
1
Hernia
1
1
Chills
1
1
Dizziness
1
1
Ulceration
1
1
Swelling/ Edema
1
1
Respiratory Insufficiency
1
1
Bowel Perforation
1
1
Constipation
1
1
Device Embedded In Tissue or Plaque
1
1
Not Applicable
1
1
Malaise
1
1
Perforation of Esophagus
1
1
Reaction
1
1
Respiratory Tract Infection
1
1
Choking
1
1
Nasal Obstruction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien Llc
II
Apr-01-2021
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