TPLC - Total Product Life Cycle

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Device	pack, hot or cold, water circulating
Product Code	ILO
Regulation Number	890.5720
Device Class	2

Premarket Reviews
Manufacturer	Decision
ELBIO CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PAIN MANAGEMENT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	56	56
Fluid/Blood Leak	44	46
Leak/Splash	39	39
Break	35	35
Scratched Material	32	32
Insufficient Information	28	28
Device Operates Differently Than Expected	20	20
Crack	11	11
Improper or Incorrect Procedure or Method	9	9
Hole In Material	7	7
Overheating of Device	7	7
Patient Device Interaction Problem	6	6
Temperature Problem	5	5
Patient-Device Incompatibility	4	4
Excessive Heating	4	4
Sparking	3	3
Moisture Damage	3	3
Improper Flow or Infusion	3	3
Electrical /Electronic Property Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Material Protrusion/Extrusion	3	3
Inappropriate/Inadequate Shock/Stimulation	3	3
Nonstandard Device	3	3
Appropriate Term/Code Not Available	2	2
Defective Device	2	2
Fire	2	2
Mechanical Problem	2	2
Component Missing	2	2
Device Displays Incorrect Message	2	2
Material Separation	2	2
Failure to Seal	1	1
Noise, Audible	1	1
Fracture	1	1
Infusion or Flow Problem	1	1
Insufficient Flow or Under Infusion	1	1
Unintended Compatibility	1	1
Fail-Safe Design Failure	1	1
Electronic Property Issue	1	1
Grounding Malfunction	1	1
Missing Information	1	1
No Apparent Adverse Event	1	1
Electrical Shorting	1	1
Difficult or Delayed Activation	1	1
Use of Device Problem	1	1
Microbial Contamination of Device	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Deflation Problem	1	1
Burst Container or Vessel	1	1
Material Rupture	1	1
Inflation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	128	128
Burn(s)	35	35
No Consequences Or Impact To Patient	27	29
Partial thickness (Second Degree) Burn	19	20
Swelling	16	16
Erythema	15	15
Burn, Thermal	11	11
No Information	10	10
Pain	10	10
Full thickness (Third Degree) Burn	9	9
No Clinical Signs, Symptoms or Conditions	9	9
Necrosis	8	8
Skin Discoloration	6	6
Injury	6	6
Electric Shock	5	5
Superficial (First Degree) Burn	4	4
Tissue Damage	4	4
Tissue Breakdown	3	3
Hypersensitivity/Allergic reaction	3	3
No Code Available	3	3
Swelling/ Edema	3	3
Skin Irritation	3	3
Disability	3	3
Unspecified Tissue Injury	3	3
Muscle/Tendon Damage	3	3
No Patient Involvement	3	3
Rash	3	3
Fever	3	3
Numbness	3	3
Bacterial Infection	2	2
Fall	2	2
Insufficient Information	2	2
Thrombosis	2	2
Blister	2	2
Shock from Patient Lead(s)	2	2
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Impaired Healing	2	2
Paralysis	1	1
Burning Sensation	1	1
Irritation	1	1
Cellulitis	1	1
Staphylococcus Aureus	1	1
Chest Pain	1	1
Discomfort	1	1
Nerve Damage	1	1
Multiple Organ Failure	1	1
Itching Sensation	1	1
Local Reaction	1	1
Dyspnea	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Breg Inc	II	Feb-12-2013
2	Breg Inc, An Orthofix Company	II	Sep-04-2009
3	Cincinnati Sub-Zero Products Inc	II	Feb-19-2015
4	Cincinnati Sub-Zero Products Inc	II	Feb-04-2010
5	Cincinnati Sub-Zero Products LLC, a Gentherm Company	III	Aug-19-2019
6	DeRoyal Industries Inc	II	Jan-27-2014
7	Gentherm Medical, LLC	II	Jan-13-2022
8	Pro Trainers' Choice Company	II	Jun-24-2011
9	Stryker Medical Division of Stryker Corporation	III	Mar-14-2018