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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2021 73 74
2022 23 23
2023 10 10
2024 5 5
2025 6 6
2026 1 1

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
Adverse Event Without Identified Device or Use Problem 12 13
Material Split, Cut or Torn 10 10
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 4 4
Human-Device Interface Problem 3 3
Loss of or Failure to Bond 3 3
Patient-Device Incompatibility 2 2
Defective Component 2 2
Contamination 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Material Deformation 2 2
Melted 2 2
Inadequate User Interface 2 2
Material Frayed 1 1
Compatibility Problem 1 1
Separation Problem 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Wrong Label 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Difficult to Remove 1 1
Adhesive Too Strong 1 1
Delivered as Unsterile Product 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Material Separation 1 1
Device Contamination with Chemical or Other Material 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 9 9
Hypersensitivity/Allergic reaction 8 8
Skin Inflammation/ Irritation 7 7
Blister 7 7
Pain 6 6
Rash 5 5
Erythema 3 3
Ulcer 3 3
Unspecified Infection 2 2
Unspecified Tissue Injury 2 2
Tissue Breakdown 2 2
Skin Irritation 1 1
Necrosis 1 1
Hematoma 1 1
Cellulitis 1 1
Skin Erosion 1 1
Irritation 1 2
Insufficient Information 1 1
Discomfort 1 1
Contact Dermatitis 1 1
Anaphylactic Shock 1 1
Discharge 1 2
Hemorrhage/Bleeding 1 1
Skin Burning Sensation 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
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