TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	26	26
Insufficient Information	18	18
Use of Device Problem	14	14
Suction Failure	11	11
Detachment of Device or Device Component	7	7
Suction Problem	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Therapeutic or Diagnostic Output Failure	6	6
Defective Component	6	6
Mechanical Problem	5	5
Pressure Problem	4	4
Appropriate Term/Code Not Available	4	4
Material Separation	3	3
Product Quality Problem	3	3
Decrease in Suction	3	3
Material Rupture	3	3
Defective Device	3	3
Material Split, Cut or Torn	2	2
Device Dislodged or Dislocated	2	2
Human-Device Interface Problem	1	1
Failure to Deflate	1	1
Fitting Problem	1	1
Device Slipped	1	1
Disconnection	1	1
Leak/Splash	1	1
Activation Problem	1	1
Output Problem	1	1
Deflation Problem	1	1
No Pressure	1	1
Material Fragmentation	1	1
Component Missing	1	1
Gas/Air Leak	1	1
Dent in Material	1	1
Crack	1	1
Pumping Problem	1	1
Expiration Date Error	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	26	26
No Known Impact Or Consequence To Patient	22	22
Insufficient Information	19	19
Cephalohematoma	11	11
Hematoma	9	9
Laceration(s)	9	9
Hemorrhage, Subgaleal	6	6
No Consequences Or Impact To Patient	5	5
Hemorrhage/Bleeding	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Fetal Distress	3	3
No Code Available	3	3
Skull Fracture	3	3
No Information	3	3
Intracranial Hemorrhage	3	3
Death	2	2
Bone Fracture(s)	2	2
Vaginal Mucosa Damage	2	2
Injury	2	2
Bruise/Contusion	2	2
Encephalopathy	1	1
Extreme Exhaustion	1	1
Perinatal Brain Injury	1	1
Abrasion	1	1
Edema	1	1
Blister	1	1
Easy Bruising	1	1
Foreign Body In Patient	1	1
Swelling	1	1
No Patient Involvement	1	1
Shock, Traumatic	1	1
Bradycardia	1	1
Hypoxia	1	1
Hemorrhage, Subarachnoid	1	1
Deformity/ Disfigurement	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Clinical Innovations, LLC	II	May-21-2020