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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gauge, depth
Regulation Description Depth gauge for clinical use.
Product CodeHTJ
Regulation Number 888.4300
Device Class 1

MDR Year MDR Reports MDR Events
2021 403 404
2022 316 318
2023 376 377
2024 371 371
2025 407 408
2026 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1026 1027
Material Deformation 552 556
Mechanical Jam 105 105
Device-Device Incompatibility 89 89
Incorrect Measurement 57 57
Use of Device Problem 42 42
Fracture 36 37
Detachment of Device or Device Component 26 26
Material Integrity Problem 24 24
Illegible Information 22 22
Naturally Worn 21 21
Mechanical Problem 20 20
Device Slipped 14 14
Material Discolored 14 14
Material Twisted/Bent 13 13
No Apparent Adverse Event 11 11
Corroded 8 8
Entrapment of Device 8 8
Crack 7 7
Appropriate Term/Code Not Available 6 6
Defective Device 5 5
Tear, Rip or Hole in Device Packaging 4 4
Degraded 4 4
Failure to Cut 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Contamination /Decontamination Problem 3 3
Device Damaged Prior to Use 3 3
Device Markings/Labelling Problem 2 2
Physical Resistance/Sticking 2 2
Component Missing 1 1
Material Fragmentation 1 1
Scratched Material 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Misassembled 1 1
Difficult to Remove 1 1
Failure to Clean Adequately 1 1
Material Separation 1 1
Unintended Movement 1 1
Device Dislodged or Dislocated 1 1
Output Problem 1 1
Fitting Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Disconnection 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1796 1801
Insufficient Information 107 107
Foreign Body In Patient 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 1 1
Hemorrhage/Bleeding 1 1
Bacterial Infection 1 1
Device Embedded In Tissue or Plaque 1 1

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