TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	22	22
Insufficient Information	19	19
Use of Device Problem	12	12
Suction Failure	10	10
Mechanical Problem	6	6
Defective Component	6	6
Therapeutic or Diagnostic Output Failure	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Suction Problem	5	5
Detachment of Device or Device Component	4	4
Pressure Problem	3	3
Decrease in Suction	3	3
Product Quality Problem	3	3
Defective Device	2	2
Material Separation	2	2
Leak/Splash	1	1
Device Slipped	1	1
Material Split, Cut or Torn	1	1
Output Problem	1	1
Crack	1	1
Pumping Problem	1	1
Expiration Date Error	1	1
Component Missing	1	1
Material Rupture	1	1
Appropriate Term/Code Not Available	1	1
Failure to Deflate	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	32	32
Insufficient Information	20	20
Cephalohematoma	9	9
Laceration(s)	9	9
Hematoma	8	8
No Known Impact Or Consequence To Patient	6	6
Hemorrhage/Bleeding	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Fetal Distress	3	3
No Code Available	3	3
Skull Fracture	3	3
Intracranial Hemorrhage	3	3
No Consequences Or Impact To Patient	3	3
Bruise/Contusion	3	3
Bone Fracture(s)	2	2
Abrasion	2	2
Encephalopathy	1	1
Extreme Exhaustion	1	1
Perinatal Brain Injury	1	1
Blister	1	1
Easy Bruising	1	1
Vaginal Mucosa Damage	1	1
Foreign Body In Patient	1	1
No Patient Involvement	1	1
Hemorrhage, Subgaleal	1	1
Bradycardia	1	1
Swelling/ Edema	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