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 sling, arm
Product CodeILI
Regulation Number 890.3640
Device Class 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 1 1
2017 2 2
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 2 2
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Nerve Damage 2 2
Pain 2 2
Rash 2 2
Skin Irritation 2 2
Hyperesthesia 2 2
Swelling/ Edema 1 1
Dizziness 1 1
Malaise 1 1
No Known Impact Or Consequence To Patient 1 1
Abrasion 1 1
Fatigue 1 1
Headache 1 1
Nausea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DJ Orthopedics de Mexico S.A. de C.V. II Apr-29-2021
2 Owens & Minor Distribution, Inc. II Dec-22-2016
-
-