Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device adaptor, hygiene
Regulation Description Daily activity assist device.
Product CodeILS
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2020 32 33
2021 27 27
2022 45 45
2023 59 59
2024 37 37
2025 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Break 35 36
Material Integrity Problem 27 27
Collapse 24 24
Insufficient Information 22 22
Fracture 21 21
Material Twisted/Bent 17 17
Adverse Event Without Identified Device or Use Problem 14 14
Mechanical Problem 12 12
Appropriate Term/Code Not Available 12 12
Detachment of Device or Device Component 10 10
Unintended Movement 8 8
Material Fragmentation 6 6
Device Dislodged or Dislocated 6 6
Misassembly by Users 5 5
Material Separation 5 5
Loose or Intermittent Connection 5 5
Device Tipped Over 4 4
Use of Device Problem 4 4
Unstable 3 3
Crack 3 3
Structural Problem 3 3
Defective Component 2 2
Installation-Related Problem 2 2
Human-Device Interface Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Slipped 1 1
Suction Failure 1 1
Material Puncture/Hole 1 1
Device Fell 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient Device Interaction Problem 1 1
Component Missing 1 1
Sharp Edges 1 1
Solder Joint Fracture 1 1
Material Deformation 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 105 106
Head Injury 26 26
Bruise/Contusion 25 25
Insufficient Information 23 23
Bone Fracture(s) 21 21
Laceration(s) 20 20
Pain 17 17
No Clinical Signs, Symptoms or Conditions 16 16
Concussion 11 11
Limb Fracture 10 10
Swelling/ Edema 7 7
Vertebral Fracture 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Hip Fracture 4 4
Skin Tears 3 3
Muscle/Tendon Damage 3 3
Neck Pain 3 3
Abrasion 3 3
Muscle Weakness 3 3
Hematoma 3 3
Unspecified Infection 3 3
Easy Bruising 2 2
Multiple Fractures 2 2
Coma 2 2
Brain Injury 2 2
Intervertebral Disc Compression or Protrusion 2 2
Loss of consciousness 2 2
Tooth Fracture 1 1
Blister 1 1
Intracranial Hemorrhage 1 1
Needle Stick/Puncture 1 1
Loss of Range of Motion 1 1
Vertigo 1 1
Inflammation 1 1
Unspecified Musculoskeletal problem 1 1
Memory Loss/Impairment 1 1
Unspecified Kidney or Urinary Problem 1 1
Joint Dislocation 1 1
Skin Infection 1 1
Ulcer 1 1
Fracture, Arm 1 1
Unspecified Heart Problem 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
Pressure Sores 1 1
Damage to Ligament(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gf Health Products II Apr-05-2021
2 James Leckey Design Ltd II Apr-08-2020
-
-