UNKNOWN-BRAVO
Received Dec 27, 2018 · Event occurred May 11, 2011
Report 9710107-2018-01093 · MDR key 8199825
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Abdominal Pain
- Chest Pain
- Headache
- Nausea
- Pain
- Burning Sensation
- Sore Throat
- Abdominal Pain
- Chest Pain
- Headache
- Nausea
- Pain
- Burning Sensation
- Sore Throat
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, THE PATIENT WAS ALREADY EXPERIENCING NAUSEA, BURNING SINUSES AND A BURNING HEADACHE. HOWEVER, AFTER THE PLACEMENT OF THE CAPSULE THE SYMPTOMS WORSEN, AND FELT NAUSEATED AND ¿FLU SICK¿. THE PATIENT TOOK CARAFATE AND EXPERIENCED CHEST PAIN AND SEVERE STOMACH BURNING. SEVEN DAYS POST PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE CAPSULE SITE AND CHEST PAINS. ELEVEN DAYS POST PROCEDURE, THE PATIENT EXPERIENCED CONSTANT PAIN IN THE STOMACH AND BURNING IN THE EUSTACHIAN TUBES AND SINUSES.