TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	265	265
Insufficient Information	51	51
Product Quality Problem	18	18
Fluid/Blood Leak	13	13
Material Split, Cut or Torn	11	11
Material Disintegration	11	11
Material Puncture/Hole	11	11
Patient Device Interaction Problem	11	11
Material Integrity Problem	9	9
Degraded	8	8
Nonstandard Device	7	7
Device Appears to Trigger Rejection	7	7
Appropriate Term/Code Not Available	7	7
Compatibility Problem	5	5
Lack of Effect	5	5
Improper or Incorrect Procedure or Method	5	5
Device Markings/Labelling Problem	4	4
Material Rupture	4	4
Break	4	4
Gel Leak	3	3
Material Separation	3	3
Device Contaminated During Manufacture or Shipping	2	2
Naturally Worn	2	2
Material Erosion	2	2
Defective Device	2	2
Contamination /Decontamination Problem	2	2
Microbial Contamination of Device	2	2
No Apparent Adverse Event	2	2
Melted	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1
Misassembly by Users	1	1
Delivered as Unsterile Product	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Physical Resistance/Sticking	1	1
Loose or Intermittent Connection	1	1
Component Missing	1	1
Material Twisted/Bent	1	1
Biocompatibility	1	1
Failure to Seal	1	1
Calcified	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Difficult to Remove	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Component	1	1
Expiration Date Error	1	1
Patient-Device Incompatibility	1	1
Device Damaged Prior to Use	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cerebrospinal Fluid Leakage	181	181
Unspecified Infection	55	55
Meningitis	36	36
Headache	29	29
Injury	25	25
Fever	23	23
No Clinical Signs, Symptoms or Conditions	19	19
Bacterial Infection	18	18
Inflammation	17	17
Failure of Implant	15	15
Fistula	12	12
Hypersensitivity/Allergic reaction	12	12
Hydrocephalus	12	12
Pain	12	12
Post Operative Wound Infection	12	12
Swelling/ Edema	11	11
No Known Impact Or Consequence To Patient	11	11
Hematoma	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Abscess	10	10
Adhesion(s)	10	10
Insufficient Information	9	9
Hemorrhage/Bleeding	8	8
Foreign Body Reaction	8	8
Unspecified Tissue Injury	7	7
Wound Dehiscence	6	6
No Consequences Or Impact To Patient	5	5
Swelling	5	5
Cerebral Edema	4	4
Numbness	4	4
Vomiting	4	4
Edema	4	4
Cyst(s)	4	4
Sepsis	4	4
Seizures	4	4
Muscle Weakness	3	3
Patient Problem/Medical Problem	3	3
Local Reaction	3	3
Discomfort	3	3
Muscle Spasm(s)	3	3
Cancer	3	3
Emotional Changes	3	3
Impaired Healing	3	3
Seroma	3	3
Bradycardia	2	2
Laceration(s)	2	2
Stenosis	2	2
Anaphylactic Shock	2	2
Hernia	2	2
Nausea	2	2