TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	666	666
Insufficient Information	369	369
Improper or Incorrect Procedure or Method	261	261
Use of Device Problem	259	259
Leak/Splash	220	220
Burst Container or Vessel	213	213
Overheating of Device	106	106
Patient-Device Incompatibility	102	102
Break	89	89
Excessive Heating	85	85
Temperature Problem	83	83
Device Operates Differently Than Expected	66	66
Nonstandard Device	55	55
Fluid/Blood Leak	47	47
Appropriate Term/Code Not Available	42	42
Unintended Ejection	40	40
Defective Device	39	39
Material Rupture	38	38
Insufficient Heating	34	34
Product Quality Problem	34	34
Explosion	29	29
Loss of or Failure to Bond	21	21
Material Deformation	18	18
Therapeutic or Diagnostic Output Failure	16	16
Material Protrusion/Extrusion	13	13
Material Integrity Problem	12	12
Unexpected Therapeutic Results	12	12
Material Split, Cut or Torn	10	10
Off-Label Use	10	10
Material Puncture/Hole	9	9
Physical Resistance/Sticking	9	9
Difficult to Remove	9	9
Device Markings/Labelling Problem	8	8
Unsealed Device Packaging	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Failure To Adhere Or Bond	6	6
Patient Device Interaction Problem	6	6
Device Slipped	5	5
Component Missing	5	5
Expiration Date Error	5	5
Defective Component	5	5
Material Separation	5	5
Packaging Problem	5	5
Chemical Spillage	4	4
Device Issue	4	4
Human-Device Interface Problem	4	4
Gel Leak	4	4
Device Emits Odor	4	4
Activation Problem	4	4
Self-Activation or Keying	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Partial thickness (Second Degree) Burn	819	820
Burn, Thermal	500	503
Pain	358	358
No Known Impact Or Consequence To Patient	218	218
No Clinical Signs, Symptoms or Conditions	175	175
Erythema	171	171
Burn(s)	165	165
Swelling	156	156
Chemical Exposure	113	113
Itching Sensation	94	95
Burning Sensation	94	94
Scarring	81	82
Superficial (First Degree) Burn	74	74
Full thickness (Third Degree) Burn	71	72
Rash	69	69
Skin Irritation	61	61
Injury	55	55
Discomfort	54	54
Skin Discoloration	52	52
Insufficient Information	48	48
Blister	46	46
Scar Tissue	37	37
Tissue Damage	36	37
No Consequences Or Impact To Patient	29	29
Hemorrhage/Bleeding	29	29
Peeling	28	28
Skin Tears	25	25
Patient Problem/Medical Problem	25	25
Hypersensitivity/Allergic reaction	24	24
No Code Available	22	22
Caustic/Chemical Burns	22	22
Fluid Discharge	21	21
Purulent Discharge	19	19
Rupture	18	18
Urticaria	18	18
Sleep Dysfunction	18	18
Unspecified Infection	18	18
Skin Inflammation	16	16
No Information	16	16
Irritation	16	16
Ulcer	16	16
Inflammation	15	15
Abrasion	14	14
Skin Inflammation/ Irritation	12	12
Skin Burning Sensation	12	12
Tissue Breakdown	10	10
Tingling	10	10
Reaction	10	10
Red Eye(s)	9	9
Discharge	9	9

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	Aug-24-2019
2	CooperSurgical, Inc.	II	Apr-07-2015
3	CooperSurgical, Inc.	II	Mar-19-2015
4	PF Consumer Healthcare 1 LLC	II	May-28-2019
5	Pfizer Global	II	Dec-16-2010
6	Pfizer Inc.	II	Dec-05-2018
7	Philips Electronics North America Corporation	II	Apr-04-2016
8	Philips Electronics North America Corporation	II	Dec-24-2015
9	Philips North America Llc	II	Jan-19-2022
10	Philips North America Llc	II	Jan-18-2022
11	Safeguard US Operating LLC	II	Sep-19-2024