TPLC - Total Product Life Cycle

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Device	electrode, circular (spiral), scalp and applicator
Product Code	HGP
Regulation Number	884.2675
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	18	18
Insufficient Information	16	16
Device Handling Problem	16	16
Material Fragmentation	12	12
Break	9	9
Detachment of Device or Device Component	8	8
Component Missing	6	6
Entrapment of Device	5	5
Positioning Problem	5	5
Separation Failure	4	4
Difficult to Remove	4	4
Use of Device Problem	3	3
Unable to Obtain Readings	2	2
Defective Component	2	2
Patient-Device Incompatibility	2	2
Device Dislodged or Dislocated	2	2
Physical Resistance/Sticking	2	2
Difficult or Delayed Separation	2	2
Therapeutic or Diagnostic Output Failure	2	2
Scratched Material	1	1
Connection Problem	1	1
Defective Device	1	1
Structural Problem	1	1
Fitting Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Signal Artifact/Noise	1	1
Disconnection	1	1
Loose or Intermittent Connection	1	1
No Device Output	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Post Operative Wound Infection	31	31
No Clinical Signs, Symptoms or Conditions	14	14
No Known Impact Or Consequence To Patient	13	13
Abrasion	12	12
Foreign Body In Patient	8	8
Device Embedded In Tissue or Plaque	7	7
Laceration(s)	6	6
Needle Stick/Puncture	6	6
Tissue Damage	5	5
Head Injury	4	4
Insufficient Information	4	4
Localized Skin Lesion	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Tissue Injury	2	2
No Consequences Or Impact To Patient	2	2
Injury	1	1
Meningitis	1	1
Burn, Thermal	1	1
Blood Loss	1	1
Post Traumatic Wound Infection	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Unspecified Infection	1	1
Swelling	1	1
Cerebrospinal Fluid Leakage	1	1
Hair Loss	1	1
Skin Inflammation/ Irritation	1	1
No Code Available	1	1
Vessel Or Plaque, Device Embedded In	1	1