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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, monitoring, intracranial pressure
Product CodeGWM
Regulation Number 882.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 260 260
2020 268 268
2021 211 211
2022 424 424
2023 746 746
2024 214 214

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 659 659
Incorrect, Inadequate or Imprecise Result or Readings 323 323
Break 245 245
Disconnection 235 235
Fracture 199 199
Output Problem 136 136
Electrical /Electronic Property Problem 68 68
Incorrect Measurement 48 48
Infusion or Flow Problem 46 46
Insufficient Information 41 41
Adverse Event Without Identified Device or Use Problem 36 36
Failure to Read Input Signal 33 33
No Device Output 31 31
Low Readings 27 27
Connection Problem 26 26
Device Dislodged or Dislocated 26 26
Complete Blockage 26 26
Loose or Intermittent Connection 24 24
Leak/Splash 23 23
Failure to Zero 22 22
Device Sensing Problem 21 21
Unable to Obtain Readings 21 21
High Readings 19 19
Appropriate Term/Code Not Available 18 18
Use of Device Problem 16 16
Display or Visual Feedback Problem 16 16
Device Difficult to Program or Calibrate 11 11
Device Displays Incorrect Message 11 11
Device-Device Incompatibility 10 10
Mechanical Problem 10 10
Pressure Problem 8 8
Erratic Results 8 8
Material Integrity Problem 7 7
Mechanical Jam 6 6
Image Display Error/Artifact 6 6
Detachment of Device or Device Component 6 6
Defective Device 6 6
Communication or Transmission Problem 6 6
Obstruction of Flow 5 5
Crack 5 5
Material Split, Cut or Torn 5 5
Material Fragmentation 4 4
Device Damaged Prior to Use 4 4
Defective Component 3 3
Failure to Sense 3 3
Battery Problem 3 3
Deformation Due to Compressive Stress 3 3
Difficult to Remove 3 3
Overheating of Device 3 3
Migration 3 3
Power Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Protective Measures Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Twisted/Bent 2 2
Audible Prompt/Feedback Problem 2 2
Difficult to Insert 2 2
Entrapment of Device 2 2
False Negative Result 2 2
Loss of or Failure to Bond 2 2
Contamination 2 2
Device Alarm System 2 2
Calibration Problem 2 2
Inappropriate Waveform 2 2
Arcing 2 2
Activation, Positioning or Separation Problem 2 2
Increase in Pressure 2 2
Shipping Damage or Problem 2 2
Material Separation 1 1
Smoking 1 1
Stretched 1 1
Unexpected Therapeutic Results 1 1
Component Missing 1 1
Dull, Blunt 1 1
Low Test Results 1 1
Device Markings/Labelling Problem 1 1
Difficult to Advance 1 1
Compatibility Problem 1 1
Sparking 1 1
Patient-Device Incompatibility 1 1
No Audible Alarm 1 1
Component Incompatible 1 1
Intermittent Continuity 1 1
Corroded 1 1
Degraded 1 1
No Display/Image 1 1
Material Frayed 1 1
Peeled/Delaminated 1 1
Failure to Run on Battery 1 1
Failure to Power Up 1 1
Failure to Reset 1 1
Material Puncture/Hole 1 1
Non Reproducible Results 1 1
Excessive Heating 1 1
Separation Problem 1 1
Premature Separation 1 1
Inaccurate Information 1 1
Unintended Electrical Shock 1 1
Air/Gas in Device 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1281 1281
No Known Impact Or Consequence To Patient 259 259
Insufficient Information 132 132
No Consequences Or Impact To Patient 124 124
Injury 63 63
Failure of Implant 61 61
Cerebrospinal Fluid Leakage 59 59
Unspecified Infection 32 32
Unspecified Tissue Injury 20 20
No Information 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Headache 11 11
Hematoma 10 10
Fever 10 10
Death 10 10
Device Embedded In Tissue or Plaque 10 10
Foreign Body In Patient 10 10
Intracranial Hemorrhage 7 7
Bacterial Infection 6 6
Patient Problem/Medical Problem 6 6
No Patient Involvement 4 4
Ambulation Difficulties 4 4
Not Applicable 4 4
Hemorrhage/Bleeding 4 4
Therapeutic Effects, Unexpected 3 3
Brain Injury 3 3
Hydrocephalus 3 3
Coma 3 3
Malaise 2 2
Impaired Healing 2 2
Meningitis 2 2
Convulsion/Seizure 2 2
Unspecified Nervous System Problem 2 2
No Code Available 2 2
Swelling/ Edema 2 2
Vomiting 2 2
Contusion 2 2
Edema 2 2
Fatigue 1 1
Death, Intrauterine Fetal 1 1
Cardiac Arrest 1 1
Muscle Weakness 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Paralysis 1 1
Perforation 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Weakness 1 1
Burning Sensation 1 1
Dizziness 1 1
Hernia 1 1
Complaint, Ill-Defined 1 1
Urinary Retention 1 1
Visual Impairment 1 1
Hemorrhage, Subarachnoid 1 1
Air Embolism 1 1
Missing Value Reason 1 1
Cough 1 1
Ventilator Dependent 1 1
Numbness 1 1
Loss of consciousness 1 1
Post Operative Wound Infection 1 1
High Oxygen Saturation 1 1
Respiratory Failure 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Vascular System (Circulation), Impaired 1 1
Fluid Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. I Dec-14-2023
2 Integra LifeSciences Corp. II May-19-2023
3 Integra LifeSciences Corp. I Jul-22-2022
4 Integra LifeSciences Corp. II Oct-12-2019
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