|
Device |
anesthesia conduction kit |
Definition |
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
Product Code | CAZ |
Regulation Number |
868.5140
|
Device Class |
2
|
Patient Problems |
MDRs with this Patient Problem |
Events in those MDRs |
No Consequences Or Impact To Patient |
1064 |
1064 |
No Clinical Signs, Symptoms or Conditions |
430 |
430 |
No Known Impact Or Consequence To Patient |
406 |
406 |
Awareness during Anaesthesia |
241 |
241 |
No Patient Involvement |
147 |
147 |
No Information |
133 |
133 |
Device Embedded In Tissue or Plaque |
129 |
129 |
Foreign Body In Patient |
103 |
103 |
Pain |
67 |
67 |
Insufficient Information |
42 |
42 |
Headache, Lumbar Puncture |
34 |
34 |
No Code Available |
28 |
28 |
Therapy/non-surgical treatment, additional |
25 |
25 |
Patient Problem/Medical Problem |
22 |
22 |
Inadequate Pain Relief |
20 |
20 |
Cerebrospinal Fluid Leakage |
18 |
18 |
Not Applicable |
18 |
18 |
Headache |
17 |
17 |
Numbness |
16 |
16 |
Perforation |
12 |
12 |
Needle Stick/Puncture |
12 |
12 |
Infiltration into Tissue |
11 |
11 |
Weakness |
10 |
10 |
Blood Loss |
10 |
10 |
Therapeutic Response, Decreased |
6 |
6 |
Discomfort |
5 |
5 |
Unspecified Infection |
5 |
5 |
Underdose |
5 |
5 |
Paralysis |
5 |
5 |
Dyspnea |
4 |
4 |
Tingling |
4 |
4 |
Therapeutic Effects, Unexpected |
4 |
4 |
Complaint, Ill-Defined |
4 |
4 |
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available |
4 |
4 |
Anxiety |
3 |
3 |
Hematoma |
3 |
3 |
Bradycardia |
2 |
2 |
Death |
2 |
2 |
Paresis |
2 |
2 |
Neurological Deficit/Dysfunction |
2 |
2 |
Low Blood Pressure/ Hypotension |
2 |
2 |
Failure of Implant |
2 |
2 |
Incontinence |
2 |
2 |
Laceration(s) |
2 |
2 |
Nausea |
2 |
2 |
Surgical procedure |
2 |
2 |
Arachnoiditis, Spinal |
2 |
2 |
Injury |
2 |
2 |
Skin Irritation |
2 |
2 |
Swelling |
2 |
2 |
Reaction |
2 |
2 |
Low Oxygen Saturation |
1 |
1 |
Decreased Sensitivity |
1 |
1 |
Test Result |
1 |
1 |
Pregnancy |
1 |
1 |
Hyperesthesia |
1 |
1 |
Unspecified Vascular Problem |
1 |
1 |
Urethral Stenosis/Stricture |
1 |
1 |
Tissue Damage |
1 |
1 |
Urinary Tract Infection |
1 |
1 |
Burning Sensation |
1 |
1 |
Hypoesthesia, Arm/Hand |
1 |
1 |
Hypoesthesia, Foot/Leg |
1 |
1 |
Nonresorbable materials, unretrieved in body |
1 |
1 |
Stenosis |
1 |
1 |
Extubate |
1 |
1 |
Meningitis |
1 |
1 |
Depression |
1 |
1 |
Foreign body, removal of |
1 |
1 |
Ambulation Difficulties |
1 |
1 |
Confusion/ Disorientation |
1 |
1 |
Surgical procedure, additional |
1 |
1 |
Loss of consciousness |
1 |
1 |
Irritability |
1 |
1 |
Post Operative Wound Infection |
1 |
1 |
Nerve Damage |
1 |
1 |
Undesired Nerve Stimulation |
1 |
1 |
Muscle Weakness |
1 |
1 |
Inflammation |
1 |
1 |
Neuropathy |
1 |
1 |
Pneumonia |
1 |
1 |
Pulmonary Dysfunction |
1 |
1 |
Respiratory Distress |
1 |
1 |
Sepsis |
1 |
1 |
Chest Pain |
1 |
1 |
Aneurysm |
1 |
1 |
Exposure to Body Fluids |
1 |
1 |
Wound Dehiscence |
1 |
1 |
Vessel Or Plaque, Device Embedded In |
1 |
1 |
Abdominal Pain |
1 |
1 |
Hemorrhage/Bleeding |
1 |
1 |
Hypersensitivity/Allergic reaction |
1 |
1 |
High Blood Pressure/ Hypertension |
1 |
1 |
Erythema |
1 |
1 |
Extravasation |
1 |
1 |
Foreign Body Reaction |
1 |
1 |
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