TPLC - Total Product Life Cycle

• Device: bandage, elastic
• Product Code: FQM
• Regulation Number: 880.5075
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	5	5
2015	8	8
2016	10	10
2017	8	8
2018	13	13
2019	10	10
2020	64	64
2021	73	73
2022	23	23
2023	10	10
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	47	47
Failure to Unfold or Unwrap	36	36
Adverse Event Without Identified Device or Use Problem	30	30
Mechanical Problem	24	24
Device Difficult to Setup or Prepare	19	19
Nonstandard Device	15	15
Appropriate Term/Code Not Available	11	11
Material Split, Cut or Torn	10	10
Patient-Device Incompatibility	8	8
Physical Resistance/Sticking	8	8
Insufficient Information	7	7
Difficult to Fold, Unfold or Collapse	6	6
Device Operates Differently Than Expected	5	5
Product Quality Problem	5	5
Material Puncture/Hole	5	5
Difficult to Remove	4	4
Use of Device Problem	3	3
Loss of or Failure to Bond	3	3
Melted	2	2
Material Frayed	2	2
Contamination /Decontamination Problem	2	2
Delivered as Unsterile Product	2	2
Human-Device Interface Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Defective Component	2	2
Device Contamination with Chemical or Other Material	2	2
Material Deformation	2	2
Material Too Rigid or Stiff	2	2
Device Packaging Compromised	2	2
Patient Device Interaction Problem	2	2
Inadequate User Interface	2	2
Packaging Problem	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Separation Problem	1	1
Defective Device	1	1
Biocompatibility	1	1
Device Damaged Prior to Use	1	1
Loose or Intermittent Connection	1	1
Off-Label Use	1	1
Device Emits Odor	1	1
Device Handling Problem	1	1
Material Separation	1	1
Material Fragmentation	1	1
Incomplete or Missing Packaging	1	1
Sticking	1	1
Device Contamination With Biological Material	1	1
Leak/Splash	1	1
Adhesive Too Strong	1	1
Compatibility Problem	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	101	101
No Patient Involvement	36	36
No Consequences Or Impact To Patient	23	23
Itching Sensation	15	15
Pain	11	11
Reaction	10	11
Rash	9	10
Hypersensitivity/Allergic reaction	7	7
No Known Impact Or Consequence To Patient	7	7
Skin Inflammation/ Irritation	6	6
Blister	5	5
Skin Irritation	5	5
Ulcer	4	4
Erythema	4	4
Pulmonary Embolism	4	4
Laceration(s)	4	5
Necrosis	4	4
No Information	3	3
No Code Available	3	3
Tissue Breakdown	2	2
Skin Tears	2	2
Ischemia	2	2
Local Reaction	2	2
Anaphylactic Shock	2	2
Hematoma	2	2
Hemorrhage/Bleeding	2	2
Unspecified Infection	2	2
Skin Erosion	2	3
Infection, Direct	2	2
Complaint, Ill-Defined	2	2
Injury	2	2
Numbness	1	1
Post Traumatic Wound Infection	1	1
Discomfort	1	1
Swelling	1	1
Ulceration	1	1
Burning Sensation	1	1
Tingling	1	1
Peeling	1	1
Discharge	1	1
Irritation	1	1
Burn(s)	1	1
Cellulitis	1	1
Scarring	1	1
Skin Discoloration	1	1
Wound Dehiscence	1	1
Caustic/Chemical Burns	1	1
Partial thickness (Second Degree) Burn	1	1
Not Applicable	1	1
Skin Burning Sensation	1	1
Contact Dermatitis	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ASO LLC	II	Aug-12-2022
2	Afassco Inc	II	Aug-08-2012
3	Amd-Ritmed, Inc.	II	Jul-15-2016
4	Andover Healthcare Inc.	II	Oct-23-2019
5	BSN Medical Inc	II	Jun-03-2022
6	Cardinal Health	II	Jan-16-2009
7	Johnson & Johnson Consumer, Inc.	II	Mar-27-2018
8	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
9	Medline Industries Inc	II	Dec-29-2017
10	Medline Industries Inc	II	Jan-23-2017
11	Medline Industries Inc	II	May-21-2014
12	North American Rescue LLC.	II	Sep-25-2020
13	Tactical Medical Solutions, Inc.	II	Jul-25-2018