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	16	16
Use of Device Problem	14	14
Suction Failure	11	11
Detachment of Device or Device Component	7	7
Suction Problem	7	7
Defective Component	6	6
Therapeutic or Diagnostic Output Failure	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Mechanical Problem	5	5
Pressure Problem	4	4
Appropriate Term/Code Not Available	4	4
Defective Device	3	3
Product Quality Problem	3	3
Material Rupture	3	3
Material Separation	3	3
Decrease in Suction	3	3
Material Split, Cut or Torn	2	2
Device Dislodged or Dislocated	2	2
Gas/Air Leak	1	1
Human-Device Interface Problem	1	1
Pumping Problem	1	1
No Pressure	1	1
Output Problem	1	1
Activation Problem	1	1
Failure to Deflate	1	1
Deflation Problem	1	1
Disconnection	1	1
Material Fragmentation	1	1
Leak/Splash	1	1
Device Slipped	1	1
Component Missing	1	1
Dent in Material	1	1
Expiration Date Error	1	1
Fitting Problem	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	22	22
Insufficient Information	19	19
No Clinical Signs, Symptoms or Conditions	19	19
Cephalohematoma	11	11
Hematoma	8	8
Laceration(s)	7	7
Hemorrhage, Subgaleal	6	6
No Consequences Or Impact To Patient	5	5
Hemorrhage/Bleeding	4	4
Intracranial Hemorrhage	3	3
Skull Fracture	3	3
Fetal Distress	3	3
No Information	3	3
No Code Available	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Injury	2	2
Vaginal Mucosa Damage	2	2
Bone Fracture(s)	2	2
Bruise/Contusion	2	2
Death	2	2
Edema	1	1
Encephalopathy	1	1
Extreme Exhaustion	1	1
Perinatal Brain Injury	1	1
Abrasion	1	1
Bradycardia	1	1
Swelling	1	1
Shock, Traumatic	1	1
Hemorrhage, Subarachnoid	1	1
Hypoxia	1	1
Deformity/ Disfigurement	1	1
Blister	1	1
Easy Bruising	1	1
No Patient Involvement	1	1
Foreign Body In Patient	1	1

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