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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
2020 64 64
2021 73 73
2022 23 23
2023 10 10
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 45 45
Failure to Unfold or Unwrap 36 36
Mechanical Problem 24 24
Device Difficult to Setup or Prepare 19 19
Adverse Event Without Identified Device or Use Problem 17 17
Nonstandard Device 14 14
Material Split, Cut or Torn 10 10
Physical Resistance/Sticking 8 8
Difficult to Fold, Unfold or Collapse 6 6
Material Puncture/Hole 5 5
Product Quality Problem 5 5
Insufficient Information 4 4
Patient-Device Incompatibility 3 3
Human-Device Interface Problem 3 3
Loss of or Failure to Bond 3 3
Defective Component 2 2
Patient Device Interaction Problem 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
Compatibility Problem 1 1
Separation Problem 1 1
Device Damaged Prior to Use 1 1
Defective Device 1 1
Contamination 1 1
Difficult to Remove 1 1
Material Fragmentation 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 101 101
No Patient Involvement 30 30
No Consequences Or Impact To Patient 23 23
Itching Sensation 9 9
Pain 8 8
Hypersensitivity/Allergic reaction 7 7
Skin Inflammation/ Irritation 6 6
Blister 6 6
Rash 6 6
Ulcer 4 4
Erythema 3 3
Unspecified Infection 2 2
Skin Irritation 2 2
Tissue Breakdown 2 2
Infection, Direct 2 2
Tingling 1 1
No Code Available 1 1
Not Applicable 1 1
Necrosis 1 1
Hematoma 1 1
Local Reaction 1 1
Post Traumatic Wound Infection 1 1
No Known Impact Or Consequence To Patient 1 1
Cellulitis 1 1
Injury 1 1
Skin Erosion 1 1
Irritation 1 1
Numbness 1 1
Insufficient Information 1 1
Discomfort 1 1
Peeling 1 1
Reaction 1 1
Contact Dermatitis 1 1
Anaphylactic Shock 1 1
Discharge 1 1
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 Sep-06-2024
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 North American Rescue LLC. II Sep-25-2020
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