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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stocking, medical support (to prevent pooling of blood in legs)
Product CodeDWL
Regulation Number 880.5780
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BAUERFEIND AG
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSSONG HOSIERY MILLS, INC
  SUBSTANTIALLY EQUIVALENT 1
BSN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DM SYSTEMS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ENCIRCLE MEDICAL DEVICES LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRIFFITHS AND NIELSEN LTD
  SUBSTANTIALLY EQUIVALENT 1
I-MING SANITARY MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KNIT-RITE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE, INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENFRO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL APPLIANCE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TSUNG HAU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2017 4 4
2018 2 2
2019 1 1
2020 3 3
2021 2 2
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Product Quality Problem 2 2
Device Operates Differently Than Expected 2 2
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Therapy Delivered to Incorrect Body Area 1 1
Device Slipped 1 1
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1
Break 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Fall 2 2
Injury 2 2
No Information 2 2
Bruise/Contusion 2 2
Edema 1 1
Muscle/Tendon Damage 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Skin Tears 1 1
No Known Impact Or Consequence To Patient 1 1
Full thickness (Third Degree) Burn 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Nerve Damage 1 1
Paralysis 1 1
Rash 1 1
Scarring 1 1
Ulcer 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer, Inc. II May-10-2014
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