TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ANHUI JBH MEDICAL APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOWHEAD DESIGN CORP.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN SHUNKANGDA MEDICAL TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI RUILANGDE MEDICAL EQUIPMENT TECHNOLOGY GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., , LTD.
	SUBSTANTIALLY EQUIVALENT	2
KARMA MOBILITY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
KI MOBILITY, LLC
	SUBSTANTIALLY EQUIVALENT	2
LICHTMEGA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MOBILITY SOURCE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD
	SUBSTANTIALLY EQUIVALENT	3
PANTHERA AB
	SUBSTANTIALLY EQUIVALENT	1
POWER PLUS MOBILITY
	SUBSTANTIALLY EQUIVALENT	1
ROUGHRIDER AMERICA, LLC
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN AST MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
TURBO WHEELCHAIR CO., INC.
	SUBSTANTIALLY EQUIVALENT	1
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	212	214
Mechanical Problem	49	49
Insufficient Information	33	33
Appropriate Term/Code Not Available	31	31
Break	30	31
Adverse Event Without Identified Device or Use Problem	22	22
Use of Device Problem	20	20
Defective Component	18	18
Material Integrity Problem	10	10
Sharp Edges	9	9
Mechanics Altered	9	9
Fracture	8	8
Human-Device Interface Problem	7	7
Improper or Incorrect Procedure or Method	6	6
Device Slipped	6	6
Component Missing	6	6
Misassembly by Users	4	4
Material Twisted/Bent	4	4
Loose or Intermittent Connection	3	4
Unintended Movement	3	3
Material Split, Cut or Torn	3	3
Electromagnetic Interference	2	3
Protective Measures Problem	2	2
Installation-Related Problem	2	2
Device Unsafe to Use in Environment	2	2
Solder Joint Fracture	2	2
Compatibility Problem	2	2
Fail-Safe Problem	2	2
Material Fragmentation	2	2
Degraded	2	2
Misassembled During Installation	2	2
Patient Device Interaction Problem	2	2
Scratched Material	2	2
Defective Device	2	2
Device Tipped Over	2	2
Physical Resistance/Sticking	2	2
Patient-Device Incompatibility	2	2
Difficult to Fold, Unfold or Collapse	2	2
Device Damaged Prior to Use	2	2
Unstable	1	1
Misassembly During Maintenance/Repair	1	1
Unintended Deflation	1	1
Material Deformation	1	1
Device Fell	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Protrusion/Extrusion	1	1
Explosion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	244	246
Insufficient Information	90	91
Bone Fracture(s)	49	49
Fall	49	49
Laceration(s)	38	38
Limb Fracture	16	16
Bruise/Contusion	12	12
Head Injury	12	12
Pain	12	12
Hip Fracture	8	8
Abrasion	7	7
Swelling/ Edema	7	7
Concussion	6	6
Hematoma	5	5
Loss of consciousness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Unspecified Musculoskeletal problem	4	4
Multiple Fractures	4	4
Brain Injury	3	3
Crushing Injury	3	3
Strangulation	3	3
Pressure Sores	2	2
Hemorrhage/Bleeding	2	2
Convulsion/Seizure	2	2
Skin Tears	2	2
Neck Stiffness	2	2
Unspecified Tissue Injury	2	2
Muscle/Tendon Damage	2	2
Hyperextension	2	2
Burn(s)	2	2
Easy Bruising	2	2
Unspecified Mental, Emotional or Behavioural Problem	1	1
Nerve Damage	1	1
Loss of Range of Motion	1	1
Neck Pain	1	1
Intracranial Hemorrhage	1	1
Confusion/ Disorientation	1	1
Post Traumatic Wound Infection	1	1
Spinal Column Injury	1	1
Abscess	1	1
Eye Injury	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Tooth Fracture	1	1
Shaking/Tremors	1	1
Myalgia	1	1
Rupture	1	1
Skin Infection	1	1
Syncope/Fainting	1	1
Partial thickness (Second Degree) Burn	1	1
Damage to Ligament(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	TiSport, Llc	II	Nov-18-2021