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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
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
Device Difficult to Setup or Prepare 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Nonstandard Device 14 14
Material Split, Cut or Torn 10 10
Physical Resistance/Sticking 8 8
Difficult to Fold, Unfold or Collapse 6 6
Patient-Device Incompatibility 6 6
Material Puncture/Hole 5 5
Insufficient Information 5 5
Product Quality Problem 5 5
Loss of or Failure to Bond 3 3
Defective Component 2 2
Melted 2 2
Human-Device Interface Problem 2 2
Inadequate User Interface 2 2
Patient Device Interaction Problem 2 2
Contamination /Decontamination Problem 2 2
Difficult to Remove 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Material Deformation 2 2
Compatibility Problem 1 1
Separation Problem 1 1
Device Damaged Prior to Use 1 1
Defective Device 1 1
Biocompatibility 1 1
Contamination 1 1
Material Fragmentation 1 1
Adhesive Too Strong 1 1
Packaging Problem 1 1
Delivered as Unsterile Product 1 1
Device Handling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Separation 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 10 10
Pain 9 9
Hypersensitivity/Allergic reaction 7 7
Skin Inflammation/ Irritation 6 6
Rash 6 6
Blister 5 5
Skin Irritation 4 4
Ulcer 4 4
No Known Impact Or Consequence To Patient 4 4
Erythema 4 4
Unspecified Infection 2 2
Infection, Direct 2 2
Tissue Breakdown 2 2
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
Reaction 1 1
Peeling 1 1
Insufficient Information 1 1
Numbness 1 1
Discomfort 1 1
Swelling 1 1
Injury 1 1
Burning Sensation 1 1
Skin Erosion 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
No Code Available 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 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
7 North American Rescue LLC. II Sep-25-2020
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