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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
Insufficient Information
16
16
Device Handling Problem
16
16
Material Fragmentation
16
16
Failure to Read Input Signal
9
9
Entrapment of Device
9
9
Difficult to Remove
9
9
Detachment of Device or Device Component
9
9
Detachment Of Device Component
6
6
Component Missing
6
6
Positioning Problem
5
5
Human Factors Issue
5
5
Separation Failure
4
4
Failure to Disconnect
4
4
Device Operates Differently Than Expected
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Use of Device Problem
3
3
Physical Resistance/Sticking
2
2
Device Dislodged or Dislocated
2
2
Difficult or Delayed Separation
2
2
Unable to Obtain Readings
2
2
Connection Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Microbial Contamination of Device
2
2
Defective Component
2
2
Defective Device
2
2
Therapeutic or Diagnostic Output Failure
2
2
Patient-Device Incompatibility
2
2
Signal Artifact/Noise
2
2
Device Reprocessing Problem
1
1
Human-Device Interface Problem
1
1
Overheating of Device
1
1
Device Inoperable
1
1
Incorrect Measurement
1
1
Loose or Intermittent Connection
1
1
Improper or Incorrect Procedure or Method
1
1
Sticking
1
1
Difficult to Insert
1
1
Shelf Life Exceeded
1
1
Scratched Material
1
1
Bent
1
1
Patient Device Interaction Problem
1
1
Data Problem
1
1
Malposition of Device
1
1
Disconnection
1
1
Structural Problem
1
1
No Device Output
1
1
Fitting Problem
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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