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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 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
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
Patient-Device Incompatibility 6 6
Difficult to Fold, Unfold or Collapse 6 6
Material Puncture/Hole 5 5
Product Quality Problem 5 5
Insufficient Information 5 5
Loss of or Failure to Bond 3 3
Melted 2 2
Difficult to Remove 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Defective Component 2 2
Material Deformation 2 2
Patient Device Interaction Problem 2 2
Contamination /Decontamination Problem 2 2
Human-Device Interface Problem 2 2
Inadequate User Interface 2 2
Compatibility Problem 1 1
Packaging Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Biocompatibility 1 1
Device Handling Problem 1 1
Separation Problem 1 1
Adhesive Too Strong 1 1
Defective Device 1 1
Device Damaged Prior to Use 1 1
Material Separation 1 1
Delivered as Unsterile Product 1 1
Contamination 1 1
Material Fragmentation 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
Skin Inflammation/ Irritation 6 6
Hypersensitivity/Allergic reaction 6 6
Rash 6 6
Blister 5 5
No Known Impact Or Consequence To Patient 4 4
Ulcer 4 4
Skin Irritation 4 4
Erythema 4 4
Unspecified Infection 2 2
Tissue Breakdown 2 2
Infection, Direct 2 2
Not Applicable 1 1
No Code Available 1 1
Skin Burning Sensation 1 1
Contact Dermatitis 1 1
Insufficient Information 1 1
Discomfort 1 1
Injury 1 1
Reaction 1 1
Numbness 1 1
Post Traumatic Wound Infection 1 1
Caustic/Chemical Burns 1 1
Peeling 1 1
Discharge 1 1
Irritation 1 1
Necrosis 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Wound Dehiscence 1 1
Anaphylactic Shock 1 1
Cellulitis 1 1
Swelling 1 1
Burning Sensation 1 1
Tingling 1 1
Local Reaction 1 1
Skin Discoloration 1 1
Skin Erosion 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 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 North American Rescue LLC. II Sep-25-2020
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