TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
DEEPWELL DTX INC.
	SUBSTANTIALLY EQUIVALENT	1
EEG SOFTWARE LLC
	SUBSTANTIALLY EQUIVALENT	1
GRAYMATTERS HEALTH LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDOTECH A/S
	SUBSTANTIALLY EQUIVALENT	1
MYOTRONICS-NOROMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
NFANT LABS, LLC
	SUBSTANTIALLY EQUIVALENT	1
PALO ALTO HEALTH SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
POWER MEDICAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SUNSTAR SUISSE S.A.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7	7
Break	3	3
Material Protrusion/Extrusion	2	2
Insufficient Information	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Appropriate Term/Code Not Available	1	1
Unexpected Therapeutic Results	1	1
Nonstandard Device	1	1
Scratched Material	1	1
Patient Device Interaction Problem	1	1
Device Unsafe to Use in Environment	1	1
Material Rupture	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Sleep Dysfunction	5	5
Visual Disturbances	3	3
Anxiety	3	3
Complaint, Ill-Defined	2	2
Irritability	2	2
Headache	2	2
Brain Injury	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Memory Loss/Impairment	2	2
Cognitive Changes	2	2
Shaking/Tremors	2	2
Confusion/ Disorientation	2	2
No Known Impact Or Consequence To Patient	2	2
Tachycardia	2	2
Foreign Body In Patient	2	2
Reaction	2	2
Muscle Spasm(s)	2	2
Insufficient Information	2	2
Ambulation Difficulties	1	1
Low Blood Pressure/ Hypotension	1	1
Tinnitus	1	1
Cough	1	1
Vascular System (Circulation), Impaired	1	1
Fall	1	1
Pain	1	1
Laceration(s)	1	1
Muscular Rigidity	1	1
Diarrhea	1	1
Depression	1	1
Numbness	1	1
Discomfort	1	1
Injury	1	1
Weakness	1	1
Blinking, Excessive	1	1
Pericardial Effusion	1	1
Disability	1	1
Dizziness	1	1
Fatigue	1	1
Emotional Changes	1	1
Abdominal Pain	1	1
Dysphasia	1	1