CAPSULE ENDOSCOPY
Received Oct 20, 2022 · Event occurred Oct 15, 2022
Report MW5112783 · MDR key 15651671
Device
Generic name
Colon Capsule Imaging System
Manufacturer
UnkProduct problems
- Patient-Device Incompatibility
Patient
40 YR · Male
- Abdominal Pain
- Diarrhea
- Dyspnea
- Fatigue
- Fever
- Low Blood Pressure/ Hypotension
- Inflammation
- Nausea
- Pain
- Dizziness
- Arthralgia
- Numbness
- Irritability
- Confusion/ Disorientation
- Lethargy
- Constipation
- Paresthesia
- Unspecified Eye / Vision Problem
- Abdominal Pain
- Diarrhea
- Dyspnea
- Fatigue
- Fever
- Low Blood Pressure/ Hypotension
- Inflammation
- Nausea
- Pain
- Dizziness
- Arthralgia
- Numbness
- Irritability
- Confusion/ Disorientation
- Lethargy
- Constipation
- Paresthesia
- Unspecified Eye / Vision Problem
Narrative
Description of Event or Problem
PREPARED 24 HOURS PRIOR FOR CAPSULE ENDOSCOPY, NECESSARY FLUSH OF GI(GASTROINTESTINAL) TRACT AND ABSTAINED FROM EATING. ON (B)(6) 2022 ATTENDED OUTPATIENT PROCEDURE, INGESTING CAPSULE AT 1148 PST AND HAD AFFIXED MONITORING EQUIPMENT TO TORSO. AT 1400 PST, WAS ABLE TO CONSUME A LIGHT MEAL, AND AT 1730 PST ABLE TO EAT NORMAL. PASSED THE CAPSULE ON (B)(6) 2022 AT 0100 PST. SEVERE SYMPTOMS BEGAN (B)(6) 2022, WHICH INCLUDED JOINT PAIN THROUGHOUT BODY, EXTREME FATIGUE, CONSTIPATION AND DIARRHEA, SEVERE NAUSEA, HYPOTENSION EPISODES, TEMPORARY LOSS OF VISION, SHORTNESS OF BREATH, DIZZINESS, LETHARGY, SEVERE BACK PAIN, NUMBNESS & TINGLING IN LIMBS, CONFUSION, IRRITABILITY, MOUTH SORES, GI TRACT INFLAMMATION, LOW GRADE FEVER, CONCENTRATION AND COMPREHENSION NEGATIVELY EFFECTED, AND EXTREME GI (SPECIFICALLY THE TRANSVERSE COLON) PAIN. FDA SAFETY REPORT ID # (B)(4).