TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	39	39
Insufficient Information	27	27
Device Operates Differently Than Expected	19	19
Use of Device Problem	15	15
Suction Problem	15	15
Suction Failure	12	12
Detachment of Device or Device Component	11	11
Adverse Event Without Identified Device or Use Problem	11	11
Decrease in Suction	8	8
Appropriate Term/Code Not Available	8	8
Detachment Of Device Component	7	7
Material Separation	7	7
Therapeutic or Diagnostic Output Failure	6	6
Defective Component	6	6
Mechanical Problem	5	5
Pressure Problem	4	4
Defective Device	4	4
Product Quality Problem	3	3
Difficult to Remove	3	3
Material Rupture	3	3
Device Inoperable	2	2
Disconnection	2	2
Sticking	2	2
Material Split, Cut or Torn	2	2
Crack	2	2
Pumping Problem	2	2
Material Fragmentation	2	2
No Pressure	2	2
Dent in Material	2	2
Failure to Pump	2	2
Device Dislodged or Dislocated	2	2
Entrapment of Device	2	2
Device Contamination with Chemical or Other Material	1	1
Material Integrity Problem	1	1
Expiration Date Error	1	1
Activation Problem	1	1
Output Problem	1	1
Material Deformation	1	1
Mechanical Jam	1	1
Failure to Disconnect	1	1
Improper or Incorrect Procedure or Method	1	1
Human-Device Interface Problem	1	1
Connection Problem	1	1
Failure to Deflate	1	1
Protective Measures Problem	1	1
Unintended Ejection	1	1
Component Missing	1	1
Gas/Air Leak	1	1
Failure To Adhere Or Bond	1	1
Deflation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	46	46
No Clinical Signs, Symptoms or Conditions	26	26
Insufficient Information	19	19
No Consequences Or Impact To Patient	15	15
Cephalohematoma	15	15
Hemorrhage, Subgaleal	12	12
Hematoma	12	12
Laceration(s)	11	11
No Information	9	9
Death	7	7
Hemorrhage/Bleeding	6	6
No Code Available	6	6
Skull Fracture	6	6
Bone Fracture(s)	4	4
Abrasion	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Fetal Distress	3	3
Perinatal Brain Injury	3	3
Intracranial Hemorrhage	3	3
Bruise/Contusion	2	2
Bradycardia	2	2
No Patient Involvement	2	2
Injury	2	2
Vaginal Mucosa Damage	2	2
Hemorrhage, Subdural	2	2
Rupture	2	2
Suffocation	2	2
Blister	1	1
Pallor	1	1
Easy Bruising	1	1
Edema	1	1
Foreign Body In Patient	1	1
Exposure to Body Fluids	1	1
Swelling	1	1
Head Injury	1	1
Occlusion	1	1
Brain Injury	1	1
Pain	1	1
Shock, Traumatic	1	1
Tachycardia	1	1
Tissue Damage	1	1
Hypoxia	1	1
Extreme Exhaustion	1	1
Encephalopathy	1	1
Bacterial Infection	1	1
Hemorrhage, Subarachnoid	1	1
Deformity/ Disfigurement	1	1
Hypoxia in Utero	1	1
Patient Problem/Medical Problem	1	1

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