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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 367 367

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 705 705
Incorrect, Inadequate or Imprecise Result or Readings 329 329
Disconnection 269 269
Break 259 259
Fracture 212 212
Output Problem 148 148
Electrical /Electronic Property Problem 69 69
Infusion or Flow Problem 54 54
Incorrect Measurement 53 53
Insufficient Information 48 48
Adverse Event Without Identified Device or Use Problem 36 36
Failure to Read Input Signal 34 34
No Device Output 33 33
Device Dislodged or Dislocated 31 31
Loose or Intermittent Connection 30 30
Complete Blockage 30 30
Leak/Splash 29 29
Low Readings 27 27
Connection Problem 26 26
Display or Visual Feedback Problem 26 26
Unable to Obtain Readings 24 24
Device Sensing Problem 22 22
Failure to Zero 22 22
High Readings 21 21
Appropriate Term/Code Not Available 18 18
Use of Device Problem 16 16
Device Displays Incorrect Message 11 11
Device Difficult to Program or Calibrate 11 11
Mechanical Problem 10 10
Device-Device Incompatibility 10 10
Erratic Results 10 10
Pressure Problem 8 8
Image Display Error/Artifact 8 8
Material Integrity Problem 7 7
Mechanical Jam 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
Erratic or Intermittent Display 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
Component Missing 2 2
Low Test Results 2 2
Dull, Blunt 1 1
Material Separation 1 1
Smoking 1 1
Stretched 1 1
Unexpected Therapeutic Results 1 1
Device Markings/Labelling Problem 1 1
Difficult to Advance 1 1
Electrical Shorting 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
Program or Algorithm Execution Failure 1 1
Separation Problem 1 1
Premature Separation 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1397 1397
No Known Impact Or Consequence To Patient 259 259
Insufficient Information 165 165
No Consequences Or Impact To Patient 124 124
Injury 63 63
Failure of Implant 61 61
Cerebrospinal Fluid Leakage 59 59
Unspecified Infection 33 33
Unspecified Tissue Injury 21 21
Bacterial Infection 14 14
Hematoma 12 12
No Information 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Headache 11 11
Device Embedded In Tissue or Plaque 10 10
Foreign Body In Patient 10 10
Fever 10 10
Death 10 10
Intracranial Hemorrhage 7 7
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
Malaise 3 3
Coma 3 3
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
Edema 2 2
Contusion 2 2
Muscle Weakness 2 2
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Paralysis 1 1
Perforation 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Cardiac Arrest 1 1
Fatigue 1 1
Death, Intrauterine Fetal 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
5 Sophysa S.A. II May-15-2024
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