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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
2020 354 354
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 1262 1263
Material Deformation 600 604
Mechanical Jam 134 134
Device-Device Incompatibility 95 95
Incorrect Measurement 62 62
Use of Device Problem 44 44
Fracture 38 39
Material Twisted/Bent 35 35
Detachment of Device or Device Component 29 29
Material Integrity Problem 27 27
Mechanical Problem 24 24
Illegible Information 23 23
Naturally Worn 21 21
Material Discolored 19 19
Device Slipped 15 15
No Apparent Adverse Event 11 11
Crack 10 10
Appropriate Term/Code Not Available 9 9
Component Missing 9 9
Corroded 8 8
Entrapment of Device 8 8
Defective Device 5 5
Degraded 4 4
Tear, Rip or Hole in Device Packaging 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
Improper or Incorrect Procedure or Method 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Difficult to Remove 1 1
Misassembled 1 1
Device Dislodged or Dislocated 1 1
Separation Failure 1 1
Dull, Blunt 1 1
Fitting Problem 1 1
Material Separation 1 1
Failure to Clean Adequately 1 1
Component Misassembled 1 1
Noise, Audible 1 1
Unintended Movement 1 1
Scratched Material 1 1
Output Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Fragmentation 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1856 1861
No Consequences Or Impact To Patient 176 176
No Patient Involvement 116 116
Insufficient Information 108 108
Foreign Body In Patient 10 10
No Code Available 5 5
No Known Impact Or Consequence To Patient 4 4
Not Applicable 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Failure of Implant 1 1
Bone Fracture(s) 1 1
Injury 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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