TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	97	97
Adverse Event Without Identified Device or Use Problem	72	72
Detachment Of Device Component	12	12
Insufficient Information	10	10
Patient Device Interaction Problem	8	8
Device Operates Differently Than Expected	7	7
Break	4	4
Fungus in Device Environment	3	3
Inadequacy of Device Shape and/or Size	3	3
Device Packaging Compromised	3	3
Patient-Device Incompatibility	2	2
Unintended Collision	2	2
Mechanics Altered	2	2
Mechanical Jam	2	2
Device Markings/Labelling Problem	2	2
Component Falling	1	1
Loss of or Failure to Bond	1	1
Gel Leak	1	1
Human-Device Interface Problem	1	1
Product Quality Problem	1	1
No Apparent Adverse Event	1	1
Material Protrusion/Extrusion	1	1
Device Emits Odor	1	1
Component Missing	1	1
Scratched Material	1	1
Peeled/Delaminated	1	1
Crack	1	1
Torn Material	1	1
Off-Label Use	1	1
Improper or Incorrect Procedure or Method	1	1
Fracture	1	1
Material Rupture	1	1
Sharp Edges	1	1
Structural Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Obtain Sample	1	1
Material Integrity Problem	1	1
Positioning Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Fell	1	1
Fitting Problem	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	75	75
No Consequences Or Impact To Patient	31	31
Itching Sensation	22	22
Skin Irritation	17	17
Erythema	14	14
Rash	14	14
Irritation	11	11
Pain	10	10
Fall	9	9
Swelling	9	9
Skin Inflammation/ Irritation	8	8
Injury	6	6
Bone Fracture(s)	6	6
Unspecified Infection	5	5
Laceration(s)	5	5
No Patient Involvement	5	5
Numbness	5	5
Hypersensitivity/Allergic reaction	3	3
Pressure Sores	3	3
No Clinical Signs, Symptoms or Conditions	3	3
No Information	3	3
Cellulitis	3	3
Abrasion	3	3
Blister	3	3
Insufficient Information	2	2
Discomfort	2	2
Thrombosis	2	2
Nerve Damage	2	2
Burning Sensation	2	2
Burn(s)	2	2
Reaction	2	2
Ulceration	2	2
Rupture	2	2
Inflammation	2	2
Sprain	2	2
No Code Available	2	2
Bacterial Infection	2	2
Fungal Infection	2	2
Joint Dislocation	2	2
Bruise/Contusion	2	2
Ambulation Difficulties	2	2
Patient Problem/Medical Problem	2	2
Damage to Ligament(s)	2	2
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Muscle/Tendon Damage	1	1
Phlebitis	1	1
Limb Fracture	1	1
Fluid Discharge	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Mar-09-2018
2	Breg Inc	II	Apr-10-2014
3	DeRoyal Industries Inc	II	Dec-06-2016
4	Ossur H / F	II	Mar-31-2016
5	Townsend Design	II	Jan-05-2024
6	United Surgical Associates	II	May-23-2015