TPLC - Total Product Life Cycle

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Device	prosthesis, laryngeal (taub)
Regulation Description	Laryngeal prosthesis (Taub design).
Product Code	EWL
Regulation Number	874.3730
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	11	11
Patient-Device Incompatibility	7	7
Biofilm coating in Device	6	6
Improper or Incorrect Procedure or Method	6	6
Fluid/Blood Leak	6	6
Insufficient Information	5	5
Use of Device Problem	3	3
Fracture	3	3
Break	2	2
Migration or Expulsion of Device	2	2
Inadequacy of Device Shape and/or Size	2	2
Installation-Related Problem	2	2
Separation Problem	1	1
Entrapment of Device	1	1
Device Fell	1	1
Defective Device	1	1
Positioning Problem	1	1
Difficult to Remove	1	1
Patient Device Interaction Problem	1	1
Difficult to Insert	1	1
Use of Incorrect Control/Treatment Settings	1	1
Material Rupture	1	1
Detachment of Device or Device Component	1	1
Material Protrusion/Extrusion	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Aspiration/Inhalation	19	19
Foreign Body In Patient	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Pain	4	4
Aspiration Pneumonitis	4	4
Laceration(s) of Esophagus	2	2
Obstruction/Occlusion	2	2
Insufficient Information	2	2
Pneumonia	2	2
Stenosis	2	2
Airway Obstruction	2	2
Device Embedded In Tissue or Plaque	2	2
Failure of Implant	1	1
Sepsis	1	1
Bowel Perforation	1	1
Localized Skin Lesion	1	1
Cellulitis	1	1
Foreign Body Reaction	1	1
Post Operative Wound Infection	1	1
Osteomyelitis	1	1
Choking	1	1
Abscess	1	1
Swelling/ Edema	1	1