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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical
Regulation Description Surgical mesh.
Product CodeFTM
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ACELL, INC
  SUBSTANTIALLY EQUIVALENT 1
ACELL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLLAFIRM LLC
  SUBSTANTIALLY EQUIVALENT 1
COLORADO THERAPEUTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
CORMATRIX CARDIOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURASEAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLEXTRONICS INTERNATIONAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIFECELL CORP.
  SUBSTANTIALLY EQUIVALENT 3
MIROMATRIX MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TEI BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
TELA BIO
  SUBSTANTIALLY EQUIVALENT 1
TISSUE REGENIX GROUP PLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Appropriate Term/Code Not Available 694
Adverse Event Without Identified Device or Use Problem 631
Insufficient Information 259
Migration or Expulsion of Device 214
Migration 25
Device Operates Differently Than Expected 23
Degraded 17
Material Erosion 15
Defective Device 13
Other (for use when an appropriate device code cannot be identified) 10
Microbial Contamination of Device 9
Loss of or Failure to Bond 9
Material Split, Cut or Torn 8
Material Disintegration 8
Contamination During Use 8
Hole In Material 8
Material Perforation 7
Material Rupture 7
Split 6
Material Integrity Problem 6
Patient Device Interaction Problem 5
Device Contamination With Biological Material 4
Material Deformation 4
Break 4
Detachment of Device or device Component 4
Torn Material 3
Mechanics Altered 3
Detachment Of Device Component 3
Product Quality Problem 3
Device Appears to Trigger Rejection 3
Device Dislodged or Dislocated 3
No Apparent Adverse Event 3
Delamination 2
Failure To Adhere Or Bond 2
Device Contamination with Chemical or Other Material 2
Device Emits Odor 2
Flaked 2
Incorrect, Inadequate or Imprecise Result or Readings 2
Shelf Life Exceeded 1
Failure to Unfold or Unwrap 1
Device Expiration Issue 1
Device Or Device Fragments Location Unknown 1
Missing Value Reason 1
Entrapment of Device 1
Material Too Rigid or Stiff 1
Material Separation 1
Incomplete or Missing Packaging 1
Device Issue 1
Failure to Form Staple 1
Device Packaging Compromised 1
Material Protrusion / Extrusion 1
Ring 1
Peeled / Delaminated 1
Unintended Movement 1
Tear, Rip or Hole in Device Packaging 1
Calcified 1
Patient-Device Incompatibility 1
Human-Device Interface Problem 1
Difficult to Open or Close 1
Explanted 1
Use of Device Problem 1
Total Device Problems 2054

Recalls
Manufacturer Recall Class Date Posted
1 ACell, Inc II Mar-21-2019
2 AROA Biosurgery, LTD. II Nov-09-2018
3 Ethicon, Inc. II Apr-03-2014

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