TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	46	46
Leak/Splash	21	21
Adverse Event Without Identified Device or Use Problem	14	14
Mechanical Jam	12	12
Failure to Eject	11	11
Device-Device Incompatibility	7	7
Mechanics Altered	5	5
Chemical Problem	4	4
Loss of or Failure to Bond	4	4
Entrapment of Device	3	3
Device Contaminated During Manufacture or Shipping	2	2
Material Deformation	2	2
Packaging Problem	2	2
Connection Problem	2	2
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Off-Label Use	1	1
Malposition of Device	1	1
Output Problem	1	1
Pumping Problem	1	1
Expiration Date Error	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Difficult to Remove	1	1
Infusion or Flow Problem	1	1
Failure to Prime	1	1
Product Quality Problem	1	1
Material Separation	1	1
Explosion	1	1
Fracture	1	1
Appropriate Term/Code Not Available	1	1
Naturally Worn	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	79	79
No Consequences Or Impact To Patient	10	10
Insufficient Information	9	9
Unspecified Infection	8	8
Pain	7	7
Extravasation	7	7
Foreign Body In Patient	4	4
No Known Impact Or Consequence To Patient	3	3
Device Embedded In Tissue or Plaque	3	3
No Code Available	2	2
Abrasion	2	2
No Patient Involvement	2	2
Neuropathy	1	1
Weight Changes	1	1
Failure of Implant	1	1
Adhesion(s)	1	1
Inflammation	1	1
Synovitis	1	1
Edema	1	1
Hair Loss	1	1
Dysphagia/ Odynophagia	1	1
Non-union Bone Fracture	1	1
Joint Laxity	1	1
Hemorrhage/Bleeding	1	1
Paraplegia	1	1
Spinal Cord Injury	1	1
Nervous System Injury	1	1
Vertebral Fracture	1	1