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TPLC
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show TPLC since
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2024
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Device
electrode, electrocardiograph
Product Code
DRX
Regulation Number
870.2360
Device Class
2
Premarket Reviews
Manufacturer
Decision
AMBU A/S
SUBSTANTIALLY EQUIVALENT
1
CARDIAC LEAD TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
COMMWELL LTD.
SUBSTANTIALLY EQUIVALENT
1
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
1
HMICRO, INC.
SUBSTANTIALLY EQUIVALENT
1
I NEEDMD, INC
SUBSTANTIALLY EQUIVALENT
1
INTEGRAL PROCESS SAS
SUBSTANTIALLY EQUIVALENT
1
LEONHARD LANG GMBH
SUBSTANTIALLY EQUIVALENT
1
NIMBLEHEART, INC.
SUBSTANTIALLY EQUIVALENT
1
R & D MEDICAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SUZUKEN CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
TEAM INNOVATIONS, INC
SUBSTANTIALLY EQUIVALENT
1
VERMED, INC.
SUBSTANTIALLY EQUIVALENT
1
ZEPHYR TECHNOLOGY CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
27
27
2015
57
57
2016
37
37
2017
54
54
2018
43
43
2019
50
50
2020
53
53
2021
55
55
2022
61
61
2023
113
113
2024
55
55
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
154
154
Adverse Event Without Identified Device or Use Problem
96
96
Patient-Device Incompatibility
42
42
Connection Problem
38
38
Failure to Sense
19
19
Human-Device Interface Problem
14
14
Improper or Incorrect Procedure or Method
14
14
Fitting Problem
12
12
Appropriate Term/Code Not Available
12
12
Use of Device Problem
10
10
Device Operates Differently Than Expected
10
10
Device Sensing Problem
9
9
Patient Device Interaction Problem
9
9
No Display/Image
8
8
Incorrect Interpretation of Signal
8
8
Failure to Deliver Shock/Stimulation
8
8
Disconnection
7
7
Defective Component
7
7
Loose or Intermittent Connection
7
7
Loss of or Failure to Bond
6
6
Missing Value Reason
6
6
Detachment of Device or Device Component
6
6
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Failure to Read Input Signal
5
5
Component Missing
5
5
Material Separation
5
5
Unable to Obtain Readings
5
5
Failure To Adhere Or Bond
5
5
Physical Resistance/Sticking
4
4
Break
4
4
Biocompatibility
4
4
No Apparent Adverse Event
4
4
Electrical /Electronic Property Problem
4
4
Device Handling Problem
3
3
Mechanical Problem
3
3
Detachment Of Device Component
3
3
Overheating of Device
3
3
Failure to Transmit Record
3
3
Defective Device
3
3
Material Integrity Problem
3
3
Mechanical Jam
2
2
Device Dislodged or Dislocated
2
2
Incomplete or Missing Packaging
2
2
Device Contamination with Chemical or Other Material
2
2
Defibrillation/Stimulation Problem
2
2
Entrapment of Device
2
2
Gel Leak
2
2
Sparking
2
2
Computer Operating System Problem
1
1
Device-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
113
113
Skin Irritation
79
79
Rash
54
54
Itching Sensation
43
43
Burn(s)
42
42
No Known Impact Or Consequence To Patient
41
41
Erythema
38
38
Blister
38
38
Skin Inflammation/ Irritation
37
37
Skin Tears
33
33
Hypersensitivity/Allergic reaction
33
33
Burning Sensation
20
20
No Information
17
17
Reaction
16
16
Partial thickness (Second Degree) Burn
14
14
Lead(s), Burn(s) From
13
13
No Consequences Or Impact To Patient
13
13
Pain
12
12
Skin Discoloration
12
12
Insufficient Information
10
10
Irritation
10
10
Skin Burning Sensation
9
9
Death
8
8
Bruise/Contusion
7
7
Localized Skin Lesion
7
7
Full thickness (Third Degree) Burn
6
6
Superficial (First Degree) Burn
6
6
Tissue Damage
6
6
Swelling/ Edema
6
6
Peeling
6
6
Abrasion
6
6
Swelling
6
6
Sore Throat
5
5
Scar Tissue
5
5
Skin Inflammation
5
5
No Patient Involvement
5
5
Foreign Body In Patient
5
5
Skin Erosion
5
5
Unspecified Infection
5
5
Skin Infection
5
5
Scarring
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Local Reaction
5
5
Hemorrhage/Bleeding
4
4
Urticaria
4
4
Discomfort
4
4
Discharge
4
4
Burn, Thermal
4
4
Fluid Discharge
4
4
Purulent Discharge
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Nov-01-2021
2
3M Company - Health Care Business
II
Nov-05-2020
3
3M Company / Medical Division
II
Sep-07-2010
4
Cambridge Heart, Inc.
II
Jun-07-2010
5
ConMed Corporation
II
Mar-02-2011
6
ConvaTec
II
Apr-22-2010
7
Graphic Controls Acquisition Corporation
II
Apr-14-2022
8
Leonhard Lang Medizintechnik GmbH
II
Nov-18-2015
9
Leonhard Lang Medizintechnik GmbH
II
Mar-28-2015
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