TPLC - Total Product Life Cycle

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Device	electrode, needle, diagnostic electromyograph
Product Code	IKT
Regulation Number	890.1385
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
BIO PROTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIONEN S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION 209, INC.
	SUBSTANTIALLY EQUIVALENT	2
NATUS MANUFACTURING LIMITED
	SUBSTANTIALLY EQUIVALENT	3
RHYTHMLINK INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
SPES MEDICA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	37	37
Break	22	22
Detachment Of Device Component	8	8
Detachment of Device or Device Component	5	5
Material Twisted/Bent	5	5
Entrapment of Device	4	4
Bent	3	3
Lead(s), burn(s) from	3	3
Material Fragmentation	2	2
Device Damaged Prior to Use	2	2
Insufficient Information	2	2
Separation Failure	2	2
Difficult to Remove	2	2
Defective Device	1	1
Biocompatibility	1	1
Contamination /Decontamination Problem	1	1
Component or Accessory Incompatibility	1	1
Device Operational Issue	1	1
Material Deformation	1	1
Defective Component	1	1
Out-Of-Box Failure	1	1
Dull, Blunt	1	1
Obstruction of Flow	1	1
Failure to Advance	1	1
Device Slipped	1	1
Device Stops Intermittently	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Problem	1	1
Misassembled	1	1
False Negative Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Not Applicable	26	26
Needle Stick/Puncture	14	14
No Known Impact Or Consequence To Patient	11	11
No Clinical Signs, Symptoms or Conditions	11	11
Foreign Body In Patient	10	10
Device Embedded In Tissue or Plaque	6	6
Burn(s)	3	3
No Consequences Or Impact To Patient	2	2
Injury	2	2
Unspecified Infection	2	2
Burn, Thermal	2	2
No Patient Involvement	1	1
Patient Problem/Medical Problem	1	1
Exposure to Body Fluids	1	1
Lead(s), Burn(s) From	1	1
Inflammation	1	1
Pain	1	1
Pneumothorax	1	1
Tissue Damage	1	1
Fatigue	1	1
No Code Available	1	1