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TPLC
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show TPLC since
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Device
cannula, surgical, general & plastic surgery
Product Code
GEA
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
58
58
2019
62
62
2020
158
158
2021
149
149
2022
83
83
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Markings/Labelling Problem
112
112
Break
89
89
Device-Device Incompatibility
65
65
Adverse Event Without Identified Device or Use Problem
50
50
Delivered as Unsterile Product
37
37
Crack
23
23
Fluid/Blood Leak
15
15
Material Deformation
15
15
Contamination /Decontamination Problem
12
12
Detachment of Device or Device Component
11
11
Material Separation
10
10
Material Twisted/Bent
8
8
Mechanical Jam
8
8
Material Fragmentation
6
6
Device Contamination with Chemical or Other Material
6
6
Entrapment of Device
6
6
Device Contaminated During Manufacture or Shipping
5
5
Physical Resistance/Sticking
5
5
Tear, Rip or Hole in Device Packaging
3
3
Fracture
3
3
Insufficient Information
3
3
Appropriate Term/Code Not Available
3
3
Temperature Problem
2
2
Material Puncture/Hole
2
2
Device Slipped
2
2
Device Operates Differently Than Expected
2
2
Patient-Device Incompatibility
2
2
Material Integrity Problem
2
2
Contamination
2
2
Leak/Splash
1
1
Defective Component
1
1
Solder Joint Fracture
1
1
Partial Blockage
1
1
Detachment Of Device Component
1
1
Missing Information
1
1
Component or Accessory Incompatibility
1
1
Burst Container or Vessel
1
1
Out-Of-Box Failure
1
1
Incomplete or Missing Packaging
1
1
Device Handling Problem
1
1
Use of Device Problem
1
1
Failure to Align
1
1
Melted
1
1
Nonstandard Device
1
1
No Apparent Adverse Event
1
1
Difficult to Open or Close
1
1
Improper Flow or Infusion
1
1
Inadequate User Interface
1
1
Packaging Problem
1
1
Loss of or Failure to Bond
1
1
Material Erosion
1
1
Material Rupture
1
1
Device Damaged Prior to Use
1
1
Connection Problem
1
1
Complete Loss of Power
1
1
Disconnection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
218
218
No Consequences Or Impact To Patient
181
181
Not Applicable
27
27
No Known Impact Or Consequence To Patient
20
20
Abscess
19
19
Foreign Body In Patient
15
15
No Code Available
12
12
No Patient Involvement
12
12
Unspecified Infection
11
11
Post Operative Wound Infection
9
9
Obstruction/Occlusion
9
9
Pain
8
8
Blood Loss
7
7
Hernia
7
7
Seroma
7
7
Hematoma
6
6
Inflammation
5
5
Insufficient Information
5
5
Fever
4
4
Hemorrhage/Bleeding
4
4
No Information
3
3
Failure to Anastomose
3
3
Sepsis
3
3
Wound Dehiscence
3
3
Device Embedded In Tissue or Plaque
3
3
Needle Stick/Puncture
2
2
Burn(s)
2
2
Peritonitis
2
2
Necrosis
2
2
Abdominal Pain
2
2
Bradycardia
1
1
Cellulitis
1
1
Ectopic Pregnancy
1
1
Edema
1
1
Nausea
1
1
Thromboembolism
1
1
Swelling/ Edema
1
1
Unintended Radiation Exposure
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Low Blood Pressure/ Hypotension
1
1
Premature Labor
1
1
Adhesion(s)
1
1
Purulent Discharge
1
1
Fistula
1
1
Incontinence
1
1
Pleural Effusion
1
1
Pneumothorax
1
1
Tachycardia
1
1
Vomiting
1
1
Infection, Pyrogenic
1
1
Injury
1
1
Cardiac Tamponade
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CLINICAL LASERTHERMIA SYSTEMS AB
II
Jun-04-2021
2
Cardinal Health 200, LLC
II
Mar-09-2020
3
Genicon, Inc.
II
Jun-05-2020
4
TeDan Surgical Innovations LLC
II
May-01-2020
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