TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
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	24	24
Fluid/Blood Leak	10	10
Patient Device Interaction Problem	6	6
Excessive Heating	4	4
Unintended Electrical Shock	2	2
Device Contamination with Chemical or Other Material	2	2
Leak/Splash	1	1
Patient-Device Incompatibility	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
No Apparent Adverse Event	1	1
Electrical /Electronic Property Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Temperature Problem	1	1
Failure to Seal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	13	13
No Clinical Signs, Symptoms or Conditions	11	11
Pain	5	5
Electric Shock	4	4
Necrosis	3	3
Insufficient Information	3	3
Muscle/Tendon Damage	3	3
Unspecified Tissue Injury	3	3
Swelling/ Edema	3	3
Partial thickness (Second Degree) Burn	3	3
Tissue Breakdown	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Infection	2	2
Hypersensitivity/Allergic reaction	2	2
Blister	2	2
Full thickness (Third Degree) Burn	2	2
Urticaria	1	1
No Code Available	1	1
Skin Irritation	1	1
Disability	1	1
Local Reaction	1	1
Itching Sensation	1	1
Multiple Organ Failure	1	1
Skin Discoloration	1	1
Cellulitis	1	1
Rash	1	1
Fever	1	1
Nerve Damage	1	1
Erythema	1	1
Alteration in Body Temperature	1	1
Laceration(s)	1	1
Fall	1	1
Bacterial Infection	1	1
Inadequate Pain Relief	1	1
Skin Burning Sensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Gentherm Medical, LLC	II	Jan-13-2022