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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
2017 8 8
2018 13 13
2019 10 10
2020 64 64
2021 73 73
2022 19 19

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 21 21
Device Difficult to Setup or Prepare 19 19
Nonstandard Device 15 15
Appropriate Term/Code Not Available 11 11
Material Split, Cut or Torn 10 10
Physical Resistance/Sticking 8 8
Insufficient Information 6 6
Difficult to Fold, Unfold or Collapse 6 6
Material Puncture/Hole 5 5
Product Quality Problem 5 5
Patient-Device Incompatibility 5 5
Loss of or Failure to Bond 3 3
Difficult to Remove 2 2
Material Too Rigid or Stiff 2 2
Melted 2 2
Use of Device Problem 2 2
Defective Component 2 2
Contamination /Decontamination Problem 2 2
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Separation Problem 1 1
Device Handling Problem 1 1
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Device 1 1
Device Damaged Prior to Use 1 1
Material Separation 1 1
Sticking 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 97 97
No Patient Involvement 31 31
No Consequences Or Impact To Patient 23 23
Itching Sensation 9 9
Pain 9 9
Reaction 8 9
Rash 6 7
No Known Impact Or Consequence To Patient 5 5
Skin Irritation 5 5
Skin Inflammation/ Irritation 5 5
Pulmonary Embolism 4 4
Ulcer 3 3
No Code Available 3 3
Injury 2 2
No Information 2 2
Skin Erosion 2 3
Infection, Direct 2 2
Erythema 2 2
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 2 2
Ischemia 2 2
Wound Dehiscence 1 1
Irritation 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Anaphylactic Shock 1 1
Cellulitis 1 1
Swelling 1 1
Burning Sensation 1 1
Tingling 1 1
Peeling 1 1
Laceration(s) 1 2
Necrosis 1 1
Discomfort 1 1
Local Reaction 1 1
Skin Discoloration 1 1
Discharge 1 1
Partial thickness (Second Degree) Burn 1 1
Not Applicable 1 1
Tissue Breakdown 1 1
Numbness 1 1
Post Traumatic Wound Infection 1 1
Caustic/Chemical Burns 1 1
Skin Burning Sensation 1 1
Contact Dermatitis 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ASO LLC II Aug-12-2022
2 Andover Healthcare Inc. II Oct-23-2019
3 BSN Medical Inc II Jun-03-2022
4 Johnson & Johnson Consumer, Inc. II Mar-27-2018
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 Medline Industries Inc II Dec-29-2017
7 Medline Industries Inc II Jan-23-2017
8 North American Rescue LLC. II Sep-25-2020
9 Tactical Medical Solutions, Inc. II Jul-25-2018
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