TPLC - Total Product Life Cycle

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Device	cultured epithelial autograft
Definition	Interactive wound and burn dressing containing a live xenogeneic component. Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
Product Code	OCE
Device Class	Humanitarian Device Exemption

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	19	19
Fluid/Blood Leak	8	8
Mechanical Problem	3	3
Leak/Splash	1	1
Packaging Problem	1	1
Product Quality Problem	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
No Clinical Signs, Symptoms or Conditions	6	6
Multiple Organ Failure	6	6
Death	5	5
Insufficient Information	5	5
Respiratory Failure	2	2
Adult Respiratory Distress Syndrome	2	2
Myocardial Infarction	2	2
Renal Failure	2	2
Heart Failure/Congestive Heart Failure	2	2
Pulmonary Embolism	1	1
Internal Organ Perforation	1	1
Low Blood Pressure/ Hypotension	1	1
Airway Obstruction	1	1
Cancer	1	1
Hemorrhage/Bleeding	1	1
Thrombocytopenia	1	1
Convulsion/Seizure	1	1
Ulcer	1	1
Endocarditis	1	1
Unspecified Tissue Injury	1	1
Pneumonia	1	1
Renal Impairment	1	1
Dyspnea	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Mitral Valve Insufficiency/ Regurgitation	1	1
Hernia	1	1
Septic Shock	1	1
Retroperitoneal Hemorrhage	1	1
Thrombosis/Thrombus	1	1
Cardiac Arrest	1	1
Burn, Thermal	1	1
Valvular Insufficiency/ Regurgitation	1	1
Ischemia	1	1
Bowel Perforation	1	1
Necrosis	1	1
Gastrointestinal Hemorrhage	1	1
Respiratory Arrest	1	1
Brain Injury	1	1
Sepsis	1	1
Stroke/CVA	1	1
Unspecified Infection	1	1
Cyanosis	1	1