TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	228	229
Insufficient Information	47	47
Material Puncture/Hole	16	16
Fluid/Blood Leak	12	12
Lack of Effect	11	11
Material Disintegration	9	9
Degraded	8	8
Patient Device Interaction Problem	8	8
Failure to Seal	7	7
Nonstandard Device	6	6
Break	4	4
Material Separation	4	4
Material Integrity Problem	4	4
Material Split, Cut or Torn	4	4
Material Rupture	3	3
Device Appears to Trigger Rejection	2	2
Material Erosion	2	2
Naturally Worn	2	2
Compatibility Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Microbial Contamination of Device	2	2
Adhesive Too Strong	2	2
Appropriate Term/Code Not Available	2	2
Device Handling Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Therapeutic or Diagnostic Output Failure	1	1
Misassembly by Users	1	1
No Apparent Adverse Event	1	1
Expiration Date Error	1	1
Patient-Device Incompatibility	1	1
Biocompatibility	1	1
Contamination /Decontamination Problem	1	1
Device Markings/Labelling Problem	1	1
Device Dislodged or Dislocated	1	1
Expulsion	1	1
Material Deformation	1	1
Fitting Problem	1	1
Material Perforation	1	1
Device Damaged Prior to Use	1	1
Calcified	1	1
Contamination	1	1
Fracture	1	1
Gel Leak	1	1
Leak/Splash	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Difficult to Remove	1	1
Delivered as Unsterile Product	1	1
Off-Label Use	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cerebrospinal Fluid Leakage	151	152
Unspecified Infection	42	42
Meningitis	37	38
Headache	30	30
Bacterial Infection	19	19
Failure of Implant	19	19
No Clinical Signs, Symptoms or Conditions	19	19
Insufficient Information	16	16
Post Operative Wound Infection	16	16
Fever	14	14
Swelling/ Edema	13	13
Hematoma	13	14
Hydrocephalus	12	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Abscess	11	11
Hypersensitivity/Allergic reaction	10	10
Foreign Body Reaction	9	9
Cerebral Edema	8	8
Pain	8	8
Fistula	7	8
Hemorrhage/Bleeding	7	7
Unspecified Tissue Injury	7	8
Adhesion(s)	7	7
Fungal Infection	5	5
Cyst(s)	5	5
Inflammation	5	5
Purulent Discharge	5	5
Sepsis	4	4
Low Blood Pressure/ Hypotension	3	3
Cancer	3	3
Discomfort	3	3
Paralysis	3	3
Local Reaction	3	3
Impaired Healing	3	3
Emotional Changes	3	3
Implant Pain	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Unspecified Nervous System Problem	2	2
Wound Dehiscence	2	2
Convulsion/Seizure	2	2
Speech Disorder	2	2
Nausea	2	2
Numbness	2	2
Anaphylactic Shock	2	2
Fatigue	2	2
Fluid Discharge	2	2
Bradycardia	2	2
Hearing Impairment	1	1
Ambulation Difficulties	1	1
High Blood Pressure/ Hypertension	1	1