TPLC - Total Product Life Cycle

show TPLC since

Device	dressing, wound, hydrogel without drug and/or biologic
Product Code	NAE
Regulation Number	878.4022
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Delivered as Unsterile Product	22	22
Adverse Event Without Identified Device or Use Problem	14	14
Packaging Problem	13	13
Unsealed Device Packaging	8	8
Tear, Rip or Hole in Device Packaging	8	8
Contamination /Decontamination Problem	8	8
Device Contaminated During Manufacture or Shipping	4	4
Device Contamination with Chemical or Other Material	3	3
Patient-Device Incompatibility	2	2
Material Discolored	2	2
Device Damaged Prior to Use	2	2
Component Missing	2	2
Fluid/Blood Leak	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Biocompatibility	1	1
Failure to Obtain Sample	1	1
Device Markings/Labelling Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23	23
No Patient Involvement	8	8
Hypersensitivity/Allergic reaction	3	3
Unspecified Infection	3	3
Impaired Healing	3	3
Burning Sensation	2	2
Bacterial Infection	2	2
Dry Eye(s)	1	1
Edema	1	1
Erythema	1	1
Hematoma	1	1
Itching Sensation	1	1
Pain	1	1
Rash	1	1
Septic Shock	1	1
No Consequences Or Impact To Patient	1	1
Urticaria	1	1
Discomfort	1	1
Reaction	1	1
Tooth Fracture	1	1
Shaking/Tremors	1	1
Low Blood Pressure/ Hypotension	1	1
Abrasion	1	1
Tissue Breakdown	1	1
Skin Infection	1	1
Contact Dermatitis	1	1
Insufficient Information	1	1