TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
EMED TECHNOLOGIES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Ejection	157	157
Misfire	84	84
Break	27	27
Defective Device	24	24
Physical Resistance/Sticking	17	17
Mechanical Jam	13	13
Failure to Deliver	13	13
Therapeutic or Diagnostic Output Failure	12	12
Defective Component	11	11
Material Twisted/Bent	9	9
Fluid/Blood Leak	9	9
Output Problem	8	8
Mechanical Problem	5	5
Activation, Positioning or Separation Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Leak/Splash	5	5
Insufficient Information	4	4
Dull, Blunt	3	3
Device Slipped	3	3
Use of Device Problem	3	3
Ejection Problem	3	3
Inaccurate Delivery	3	3
Failure to Infuse	3	3
Failure to Eject	2	2
Patient-Device Incompatibility	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Improper Flow or Infusion	2	2
Difficult to Remove	2	2
Insufficient Flow or Under Infusion	2	2
Key or Button Unresponsive/not Working	2	2
Detachment of Device or Device Component	2	2
Failure to Fire	2	2
Packaging Problem	2	2
Firing Problem	1	1
Shipping Damage or Problem	1	1
Difficult to Insert	1	1
Loss of or Failure to Bond	1	1
Noise, Audible	1	1
Unexpected Therapeutic Results	1	1
Connection Problem	1	1
Naturally Worn	1	1
Use of Incorrect Control/Treatment Settings	1	1
No Flow	1	1
Improper or Incorrect Procedure or Method	1	1
No Apparent Adverse Event	1	1
Retraction Problem	1	1
Material Separation	1	1
Structural Problem	1	1
Mechanics Altered	1	1
Excess Flow or Over-Infusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	140	140
No Consequences Or Impact To Patient	124	124
No Known Impact Or Consequence To Patient	90	90
Insufficient Information	36	36
Missed Dose	14	14
Pain	8	8
Underdose	6	6
Hyperglycemia	6	6
Needle Stick/Puncture	5	5
Swelling	4	4
Bruise/Contusion	3	3
Reaction, Injection Site	3	3
Hypersensitivity/Allergic reaction	2	2
Bacterial Infection	2	2
Anxiety	2	2
Inflammation	2	2
Local Reaction	2	2
Erythema	2	2
Device Embedded In Tissue or Plaque	1	1
Hemorrhage/Bleeding	1	1
Tinnitus	1	1
Eye Injury	1	1
Dyspnea	1	1
Scar Tissue	1	1
Chest Pain	1	1
Irritation	1	1
Seroma	1	1
Injury	1	1
Foreign Body In Patient	1	1
Abrasion	1	1
Scarring	1	1
Obstruction/Occlusion	1	1
Blood Loss	1	1
Cataract	1	1
Necrosis	1	1
Sepsis	1	1
Skin Irritation	1	1
No Code Available	1	1
Arthralgia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Abdominal Pain	1	1
High Blood Pressure/ Hypertension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Owen Mumford USA, Inc.	II	Nov-01-2019