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TPLC
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show TPLC since
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Device
electrode, circular (spiral), scalp and applicator
Product Code
HGP
Regulation Number
884.2675
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
44
44
2019
26
26
2020
25
25
2021
33
33
2022
27
27
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
29
29
Adverse Event Without Identified Device or Use Problem
20
20
Insufficient Information
16
16
Device Handling Problem
16
16
Material Fragmentation
15
15
Failure to Read Input Signal
9
9
Detachment of Device or Device Component
8
8
Difficult to Remove
7
7
Component Missing
6
6
Entrapment of Device
6
6
Positioning Problem
5
5
Failure to Disconnect
4
4
Separation Failure
4
4
Detachment Of Device Component
3
3
Use of Device Problem
2
2
Defective Component
2
2
Defective Device
2
2
Patient-Device Incompatibility
2
2
Device Dislodged or Dislocated
2
2
Unable to Obtain Readings
2
2
Therapeutic or Diagnostic Output Failure
2
2
Physical Resistance/Sticking
2
2
Difficult or Delayed Separation
2
2
Patient Device Interaction Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Scratched Material
1
1
Connection Problem
1
1
Structural Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Shelf Life Exceeded
1
1
Sticking
1
1
Signal Artifact/Noise
1
1
Loose or Intermittent Connection
1
1
No Device Output
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
32
32
Post Operative Wound Infection
31
31
Device Embedded In Tissue or Plaque
16
16
Foreign Body In Patient
12
12
Abrasion
12
12
No Clinical Signs, Symptoms or Conditions
9
9
Tissue Damage
7
7
Laceration(s)
6
6
Needle Stick/Puncture
6
6
Pregnancy
4
4
Insufficient Information
4
4
Head Injury
4
4
Localized Skin Lesion
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Unspecified Tissue Injury
2
2
No Code Available
2
2
Unspecified Infection
2
2
Abscess
2
2
Swelling
2
2
No Consequences Or Impact To Patient
2
2
Injury
1
1
Meningitis
1
1
Vessel Or Plaque, Device Embedded In
1
1
Staphylococcus Aureus
1
1
Cerebrospinal Fluid Leakage
1
1
Purulent Discharge
1
1
Hair Loss
1
1
Inflammation
1
1
Hematoma
1
1
Hemorrhage/Bleeding
1
1
No Information
1
1
Burn, Thermal
1
1
Blood Loss
1
1
Post Traumatic Wound Infection
1
1
Skin Inflammation/ Irritation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Philips North America, LLC
II
May-02-2019
2
Philips North America Llc
II
Jan-06-2023
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