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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bandage, elastic
Product CodeFQM
Regulation Number 880.5075
Device Class 1

MDR Year MDR Reports MDR Events
2018 13 13
2019 10 10
2020 64 64
2021 73 73
2022 23 23
2023 10 10
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 47 47
Failure to Unfold or Unwrap 36 36
Mechanical Problem 24 24
Adverse Event Without Identified Device or Use Problem 19 19
Device Difficult to Setup or Prepare 19 19
Nonstandard Device 15 15
Material Split, Cut or Torn 10 10
Appropriate Term/Code Not Available 9 9
Physical Resistance/Sticking 8 8
Difficult to Fold, Unfold or Collapse 6 6
Patient-Device Incompatibility 6 6
Insufficient Information 6 6
Material Puncture/Hole 5 5
Product Quality Problem 5 5
Loss of or Failure to Bond 3 3
Inadequate User Interface 2 2
Human-Device Interface Problem 2 2
Melted 2 2
Material Deformation 2 2
Use of Device Problem 2 2
Material Too Rigid or Stiff 2 2
Patient Device Interaction Problem 2 2
Contamination /Decontamination Problem 2 2
Difficult to Remove 2 2
Defective Component 2 2
Adhesive Too Strong 1 1
Material Fragmentation 1 1
Delivered as Unsterile Product 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Material Separation 1 1
Sticking 1 1
Contamination 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1
Defective Device 1 1
Device Damaged Prior to Use 1 1
Incomplete or Missing Packaging 1 1
Separation Problem 1 1
Biocompatibility 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 101 101
No Patient Involvement 31 31
No Consequences Or Impact To Patient 23 23
Itching Sensation 15 15
Pain 10 10
Hypersensitivity/Allergic reaction 7 7
Rash 7 8
Reaction 7 8
Skin Inflammation/ Irritation 6 6
Skin Irritation 5 5
Blister 5 5
No Known Impact Or Consequence To Patient 5 5
Ulcer 4 4
Erythema 4 4
No Code Available 3 3
Unspecified Infection 2 2
Infection, Direct 2 2
Tissue Breakdown 2 2
No Information 2 2
Ischemia 2 2
Skin Erosion 2 3
Skin Burning Sensation 1 1
Hemorrhage/Bleeding 1 1
Caustic/Chemical Burns 1 1
Discharge 1 1
Contact Dermatitis 1 1
Anaphylactic Shock 1 1
Peeling 1 1
Laceration(s) 1 2
Insufficient Information 1 1
Numbness 1 1
Discomfort 1 1
Swelling 1 1
Injury 1 1
Burning Sensation 1 1
Irritation 1 1
Post Traumatic Wound Infection 1 1
Skin Discoloration 1 1
Cellulitis 1 1
Local Reaction 1 1
Hematoma 1 1
Necrosis 1 1
Not Applicable 1 1
Tingling 1 1
Wound Dehiscence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ASO LLC II Aug-12-2022
2 Andover Healthcare Inc. II May-15-2024
3 Andover Healthcare Inc. II Oct-23-2019
4 BSN Medical Inc II Jun-03-2022
5 Johnson & Johnson Consumer, Inc. II Mar-27-2018
6 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
7 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
8 North American Rescue LLC. II Sep-25-2020
9 Tactical Medical Solutions, Inc. II Jul-25-2018
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