TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	12	12
Insufficient Information	12	12
Patient Device Interaction Problem	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Unintended Movement	6	6
Mechanical Problem	4	4
Material Integrity Problem	4	4
Patient-Device Incompatibility	3	3
Device Slipped	3	3
Detachment of Device or Device Component	3	3
Positioning Failure	3	3
Defective Device	2	2
Positioning Problem	2	2
Fracture	2	2
Use of Device Problem	2	2
Component Missing	2	2
Appropriate Term/Code Not Available	1	1
Material Split, Cut or Torn	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Activation Problem	1	1
Structural Problem	1	1
Material Puncture/Hole	1	1
Connection Problem	1	1
Device Fell	1	1
Material Discolored	1	1
Improper or Incorrect Procedure or Method	1	1
Product Quality Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Loose or Intermittent Connection	1	1
Mechanical Jam	1	1
Component or Accessory Incompatibility	1	1
Protective Measures Problem	1	1
Material Too Rigid or Stiff	1	1
Unsealed Device Packaging	1	1
Material Separation	1	1
Physical Resistance/Sticking	1	1
Material Deformation	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	24
Pressure Sores	11	11
No Known Impact Or Consequence To Patient	10	10
Skin Inflammation/ Irritation	7	7
Unspecified Tissue Injury	5	5
Insufficient Information	5	5
Burn(s)	4	4
Erythema	4	4
Rash	4	4
Fall	3	3
Injury	2	2
No Patient Involvement	2	2
Bruise/Contusion	2	2
No Consequences Or Impact To Patient	2	2
Ulcer	2	2
Blister	2	2
Abrasion	1	1
Tissue Breakdown	1	1
Superficial (First Degree) Burn	1	1
Head Injury	1	1
Laceration(s)	1	1
Scarring	1	1
Skull Fracture	1	1
Tissue Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aspen Surgical Products, Inc.	II	Aug-30-2021