TPLC - Total Product Life Cycle

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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	22	22
Fluid/Blood Leak	9	9
Patient Device Interaction Problem	6	6
Leak/Splash	2	2
Break	2	2
Output Problem	2	2
Unintended Electrical Shock	2	2
Patient-Device Incompatibility	2	2
Device Contamination with Chemical or Other Material	2	2
Excessive Heating	2	2
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Component Missing	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	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)	11	11
No Clinical Signs, Symptoms or Conditions	10	10
Electric Shock	6	6
Pain	4	4
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
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Hypersensitivity/Allergic reaction	2	2
Blister	2	2
Urticaria	1	1
Necrosis	1	1
Itching Sensation	1	1
Local Reaction	1	1
Multiple Organ Failure	1	1
Cellulitis	1	1
Skin Discoloration	1	1
Fever	1	1
Rash	1	1
Erythema	1	1
Alteration in Body Temperature	1	1
Fall	1	1
Laceration(s)	1	1
Bacterial Infection	1	1
Inadequate Pain Relief	1	1
Full thickness (Third Degree) Burn	1	1
Skin Burning Sensation	1	1