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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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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
2014
3
3
2015
10
10
2016
3
3
2017
17
17
2018
44
44
2019
26
26
2020
25
25
2021
33
33
2022
27
27
2023
8
8
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
37
37
Adverse Event Without Identified Device or Use Problem
21
21
Device Handling Problem
16
16
Insufficient Information
16
16
Material Fragmentation
16
16
Entrapment of Device
9
9
Detachment of Device or Device Component
9
9
Difficult to Remove
9
9
Failure to Read Input Signal
9
9
Detachment Of Device Component
6
6
Component Missing
6
6
Human Factors Issue
5
5
Positioning Problem
5
5
Failure to Disconnect
4
4
Separation Failure
4
4
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Use of Device Problem
3
3
Device Operates Differently Than Expected
3
3
Signal Artifact/Noise
2
2
Therapeutic or Diagnostic Output Failure
2
2
Defective Device
2
2
Defective Component
2
2
Connection Problem
2
2
Microbial Contamination of Device
2
2
Unable to Obtain Readings
2
2
Device Contamination with Chemical or Other Material
2
2
Patient-Device Incompatibility
2
2
Difficult or Delayed Separation
2
2
Device Dislodged or Dislocated
2
2
Physical Resistance/Sticking
2
2
Device Inoperable
1
1
Overheating of Device
1
1
Fitting Problem
1
1
Device Reprocessing Problem
1
1
Disconnection
1
1
Patient Device Interaction Problem
1
1
Scratched Material
1
1
Human-Device Interface Problem
1
1
Difficult to Insert
1
1
Sticking
1
1
Incorrect Measurement
1
1
Shelf Life Exceeded
1
1
Structural Problem
1
1
Bent
1
1
Data Problem
1
1
Malposition of Device
1
1
Improper or Incorrect Procedure or Method
1
1
Loose or Intermittent Connection
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
40
40
Post Operative Wound Infection
31
31
Device Embedded In Tissue or Plaque
23
23
No Clinical Signs, Symptoms or Conditions
17
17
Foreign Body In Patient
17
17
Abrasion
12
12
Tissue Damage
11
11
Unspecified Infection
7
7
Laceration(s)
6
6
Needle Stick/Puncture
6
6
Insufficient Information
5
5
Head Injury
4
4
Injury
4
4
Pregnancy
4
4
No Code Available
4
4
Localized Skin Lesion
3
3
Skin Tears
3
3
No Consequences Or Impact To Patient
3
3
Swelling
2
2
Abscess
2
2
Unspecified Tissue Injury
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Hematoma
1
1
Purulent Discharge
1
1
Inflammation
1
1
Blood Loss
1
1
Burn, Thermal
1
1
Skin Inflammation/ Irritation
1
1
Staphylococcus Aureus
1
1
No Information
1
1
Post Traumatic Wound Infection
1
1
Nausea
1
1
No Patient Involvement
1
1
Vomiting
1
1
Pain
1
1
Abdominal Pain
1
1
Hair Loss
1
1
Cerebrospinal Fluid Leakage
1
1
Meningitis
1
1
Hemorrhage/Bleeding
1
1
Vessel Or Plaque, Device Embedded In
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
3
Vital Signs Devices, a GE Healthcare Company
II
Nov-16-2012
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