TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, ureteral, general & plastic surgery
Product Code	GBL
Regulation Number	876.5130
Device Class	Not Classified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	27	27
Break	26	26
Device Contamination with Chemical or Other Material	8	8
Material Fragmentation	5	5
Detachment Of Device Component	4	4
Insufficient Information	4	4
Migration or Expulsion of Device	4	4
Contamination /Decontamination Problem	4	4
Fracture	3	3
Detachment of Device or Device Component	3	3
Flaked	2	2
Device Damaged Prior to Use	2	2
Peeled/Delaminated	2	2
Partial Blockage	2	2
Difficult to Remove	2	2
Tip breakage	2	2
Failure to Advance	2	2
Unraveled Material	2	2
Occlusion Within Device	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Obstruction of Flow	1	1
Material Puncture/Hole	1	1
Particulates	1	1
Appropriate Term/Code Not Available	1	1
Device Operates Differently Than Expected	1	1
Bent	1	1
Device Contaminated During Manufacture or Shipping	1	1
Protective Measures Problem	1	1
Material Too Rigid or Stiff	1	1
Unsealed Device Packaging	1	1
Kinked	1	1
Entrapment of Device	1	1
Difficult to Advance	1	1
Mechanical Problem	1	1
Crack	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	32	32
No Known Impact Or Consequence To Patient	23	23
Foreign Body In Patient	12	12
No Patient Involvement	11	11
No Code Available	8	8
Device Embedded In Tissue or Plaque	6	6
Foreign body, removal of	6	6
No Information	4	4
Unspecified Infection	3	3
Internal Organ Perforation	2	2
Perforation	2	2
Insufficient Information	2	2
Thromboembolism	1	1
Erosion	1	1
Pain	1	1
Respiratory Failure	1	1
Surgical procedure, additional	1	1
Unknown (for use when the patient's condition is not known)	1	1
Nonresorbable materials, unretrieved in body	1	1