|
|
| 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 |
|
|
|
|
