TPLC - Total Product Life Cycle

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Device	dressing, wound, hydrogel without drug and/or biologic
Regulation Description	Hydrogel wound dressing and burn dressing.
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	39	39
Device Damaged Prior to Use	18	18
Unsealed Device Packaging	15	15
Tear, Rip or Hole in Device Packaging	14	14
Packaging Problem	13	13
Contamination /Decontamination Problem	12	12
Adverse Event Without Identified Device or Use Problem	10	10
Gel Leak	7	7
Device Contaminated During Manufacture or Shipping	4	4
Device Contamination with Chemical or Other Material	3	3
Material Discolored	2	2
Biocompatibility	2	2
Component Missing	2	2
Failure to Obtain Sample	1	1
Improper or Incorrect Procedure or Method	1	1
Fluid/Blood Leak	1	1
Insufficient Device Problem Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	43
No Patient Involvement	5	5
Hypersensitivity/Allergic reaction	3	3
Impaired Healing	3	3
Unspecified Infection	3	3
Bacterial Infection	2	2
Erythema	2	2
Skin Infection	1	1
Low Blood Pressure/ Hypotension	1	1
No Consequences Or Impact To Patient	1	1
Shaking/Tremors	1	1
Abrasion	1	1
Edema	1	1
Tooth Fracture	1	1
Insufficient Information	1	1
Septic Shock	1	1
Rash	1	1
Contact Dermatitis	1	1
Tissue Breakdown	1	1
Urticaria	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Nelson Innovaions, Llc	II	May-21-2020