TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Unfold or Unwrap	37	37
Device Difficult to Setup or Prepare	14	14
Nonstandard Device	13	13
Material Split, Cut or Torn	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Physical Resistance/Sticking	7	7
Material Puncture/Hole	5	5
Product Quality Problem	5	5
Difficult to Fold, Unfold or Collapse	4	4
Patient Device Interaction Problem	3	3
Human-Device Interface Problem	3	3
Loss of or Failure to Bond	3	3
Inadequate User Interface	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Deformation	2	2
Material Too Rigid or Stiff	2	2
Melted	2	2
Defective Component	2	2
Contamination	2	2
Device Emits Odor	2	2
Insufficient Device Problem Information	1	1
Difficult to Remove	1	1
Device Handling Problem	1	1
Material Separation	1	1
Device Damaged Prior to Use	1	1
Material Integrity Problem	1	1
Separation Problem	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	84	84
Itching Sensation	11	11
Hypersensitivity/Allergic reaction	8	8
Blister	7	7
Skin Inflammation/ Irritation	7	7
Pain	6	6
Rash	5	5
Ulcer	3	3
Erythema	3	3
Unspecified Tissue Injury	2	2
Unspecified Infection	2	2
Tissue Breakdown	2	2
Inflammation	2	2
Irritation	1	2
Contact Dermatitis	1	1
Skin Irritation	1	1
Cellulitis	1	1
Anaphylactic Shock	1	1
Discharge	1	2
Discomfort	1	1
Skin Burning Sensation	1	1
Skin Erosion	1	1
Insufficient Information	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Hematoma	1	1
Necrosis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ASO LLC	II	Aug-12-2022
2	Andover Healthcare Inc.	II	May-15-2024
3	BSN Medical Inc	II	Jun-03-2022
4	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-17-2025
5	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
6	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
7	Medline Industries, LP	II	Jun-25-2026