TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	35	36
Adverse Event Without Identified Device or Use Problem	15	15
Entrapment of Device	9	9
Break	8	8
Installation-Related Problem	6	6
Use of Device Problem	6	6
Insufficient Information	5	5
Improper or Incorrect Procedure or Method	3	3
Melted	3	3
Inflation Problem	3	3
Product Quality Problem	2	2
Unintended Movement	2	2
Defective Device	2	2
Material Fragmentation	2	2
Excess Flow or Over-Infusion	2	2
Dent in Material	2	2
Appropriate Term/Code Not Available	1	1
Increase in Pressure	1	1
Fracture	1	1
Device Contamination with Chemical or Other Material	1	1
Tear, Rip or Hole in Device Packaging	1	1
Difficult or Delayed Separation	1	1
Material Deformation	1	1
Material Rupture	1	1
Sharp Edges	1	1
Component Missing	1	1
Difficult to Insert	1	1
Patient Device Interaction Problem	1	1
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Integrity Problem	1	1
Defective Component	1	1
Material Puncture/Hole	1	4
Crack	1	1
Output Problem	1	1
Malposition of Device	1	1
Mechanical Problem	1	1
Burst Container or Vessel	1	1
Material Split, Cut or Torn	1	1
Device Contaminated During Manufacture or Shipping	1	1
Device Slipped	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	71	71
Insufficient Information	15	19
Laceration(s)	15	15
Foreign Body In Patient	9	9
Uterine Perforation	4	4
Abnormal Vaginal Discharge	4	4
Hemorrhage/Bleeding	3	3
Abdominal Pain	2	2
Unspecified Infection	2	2
Urinary Tract Infection	2	2
Device Embedded In Tissue or Plaque	2	2
Menstrual Irregularities	1	1
Hematuria	1	1
Perforation	1	1
Needle Stick/Puncture	1	1
Pain	1	1
Unspecified Tissue Injury	1	1
Internal Organ Perforation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	May-26-2021