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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search Show TPLC since Back To Search Results
Device expander, skin, inflatable
Product CodeLCJ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ALLERGAN
  SUBSTANTIALLY EQUIVALENT 2
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 3
MARZ MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY SURGICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRADIS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material Rupture 314
Fluid Leak 262
Adverse Event Without Identified Device or Use Problem 163
No Apparent Adverse Event 47
Break 36
Improper or Incorrect Procedure or Method 26
Device Contamination with Chemical or Other Material 21
Patient-Device Incompatibility 18
Inflation Problem 14
Insufficient Information 12
Off-Label Use 10
Appropriate Term/Code Not Available 10
Use of Device Problem 8
Leak / Splash 7
Connection Problem 6
Delivered as Unsterile Product 5
Migration or Expulsion of Device 5
Deflation Problem 4
Shipping Damage or Problem 4
Detachment of Device or device Component 4
Defective Device 3
Material Separation 3
Unsealed Device Packaging 2
Device Damaged Prior to Use 2
Malposition of device 2
Expander 2
Component Missing 2
Contamination / decontamination Problem 2
Biofilm coating in Device 2
Migration 2
Defective Component 1
Material Integrity Problem 1
Gas Leak 1
Activation Failure Including Expansion Failures 1
Loss of or Failure to Bond 1
Flaked 1
Device Markings / Labelling Problem 1
Free or Unrestricted Flow 1
Manufacturing, Packaging or Shipping Problem 1
Device Expiration Issue 1
Material Perforation 1
Incomplete or Missing Packaging 1
Device Damaged by Another Device 1
Device Packaging Compromised 1
Contamination of Device Ingredient or Reagent 1
Material Deformation 1
Total Device Problems 1014

Recalls
Manufacturer Recall Class Date Posted
1 Allergan Inc II Jul-18-2015
2 Mentor Texas, LP. II Sep-10-2016
3 Mentor Texas, LP. II Sep-07-2016

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