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TPLC
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show TPLC since
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2019
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2024
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Device
suture, absorbable, natural
Product Code
GAL
Regulation Number
878.4830
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
229
229
2020
109
109
2021
120
120
2022
130
130
2023
121
121
2024
73
73
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
428
428
Material Separation
159
159
Adverse Event Without Identified Device or Use Problem
55
55
Material Frayed
43
43
Detachment of Device or Device Component
37
37
Appropriate Term/Code Not Available
21
21
Material Integrity Problem
18
18
Patient-Device Incompatibility
15
15
Defective Component
15
15
Component Misassembled
13
13
Material Twisted/Bent
11
11
Use of Device Problem
10
10
Unraveled Material
9
9
Packaging Problem
8
8
Device Markings/Labelling Problem
7
7
Fluid/Blood Leak
6
6
Product Quality Problem
5
5
Device Contaminated During Manufacture or Shipping
5
5
Material Split, Cut or Torn
5
5
Difficult to Open or Close
4
4
Device Slipped
4
4
Difficult to Remove
3
3
Component Missing
3
3
Contamination /Decontamination Problem
3
3
Migration
2
2
Unsealed Device Packaging
2
2
Component Incompatible
2
2
Positioning Failure
1
1
Entrapment of Device
1
1
Material Fragmentation
1
1
Loose or Intermittent Connection
1
1
Delivered as Unsterile Product
1
1
Insufficient Information
1
1
Device Fell
1
1
Missing Information
1
1
Activation, Positioning or Separation Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Mechanics Altered
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
370
370
No Consequences Or Impact To Patient
245
245
Insufficient Information
28
28
Wound Dehiscence
24
24
Not Applicable
20
20
No Code Available
19
19
Hemorrhage/Bleeding
18
18
Unspecified Infection
17
17
Foreign Body In Patient
16
16
No Known Impact Or Consequence To Patient
13
13
Pain
12
12
No Patient Involvement
10
10
Swelling/ Edema
10
10
Post Operative Wound Infection
9
9
No Information
8
8
Unspecified Tissue Injury
8
8
Blood Loss
6
6
Hypersensitivity/Allergic reaction
6
6
Erythema
6
6
Foreign Body Reaction
5
5
Cyst(s)
5
5
Skin Irritation
5
5
Skin Inflammation
5
5
Incontinence
4
4
Unintended Radiation Exposure
4
4
Granuloma
4
4
Inflammation
4
4
Erosion
3
3
Abscess
3
3
Tissue Damage
3
3
Scar Tissue
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Device Embedded In Tissue or Plaque
3
3
Radiation Exposure, Unintended
2
2
Prolapse
2
2
Impaired Healing
2
2
Numbness
2
2
Obstruction/Occlusion
2
2
Blister
2
2
Abnormal Vaginal Discharge
2
2
Sepsis
2
2
Hematoma
2
2
Fistula
2
2
Itching Sensation
1
1
Laceration(s)
1
1
Necrosis
1
1
Adhesion(s)
1
1
Anaphylactic Shock
1
1
Calcium Deposits/Calcification
1
1
Edema
1
1
Seroma
1
1
Swelling
1
1
Tachycardia
1
1
Weakness
1
1
Urinary Tract Infection
1
1
Scarring
1
1
Low Blood Pressure/ Hypotension
1
1
Paralysis
1
1
Local Reaction
1
1
Respiratory Distress
1
1
Skin Inflammation/ Irritation
1
1
Stenosis
1
1
Urticaria
1
1
Discomfort
1
1
Hematuria
1
1
Tissue Breakdown
1
1
Fluid Discharge
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CP Medical Inc
II
Mar-19-2019
2
Covidien, LP
II
Apr-12-2023
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