FDA Adverse Event Injury Summary report: N

OLYMPUS ENDO CAPSULE

MDR report key: 14430012 · Received May 17, 2022

Report

Report Number
MW5109760
Event Type
Injury
Date Received
May 17, 2022
Date of Event
March 22, 2022
Report Date
May 14, 2022
Manufacturer
OLYMPUS CORPORATION OF THE AMERICAS
Product Code
NEZ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

SEE BELOW REPORT TO [email protected]; FROM: (B)(6). SENT: (B)(6) 2022; SUBJECT: OLYMPUS ENDO CAPSULE. MESSAGE: THE MANUFACTURER OF THE OLYMPUS ENDO CAPSULE HAS REFUSED TO RELEASE THE INGREDIENTS IN THE COATING ON THE CAPSULE TO MY DOCTORS, THE LOCAL HOSPITAL, OR ME. I NEED EMERGENCY ASSISTANCE WITH THIS MATTER. ON (B)(6) 2022 I HAD A CAMERA- ENDOSCOPY, SWALLOWING THE OLYMPUS ENDO CAPSULE, LOT # 2021022, EXPIRATION 5/1/2023, AT (B)(6) HOSPITAL, (B)(6), SPECIAL PROCEDURES DEPARTMENT. PRESCRIBING PHYSICIAN WAS (B)(6), (B)(6) CLINIC, (B)(6). I HAVE A CONTACT ALLERGY TO IODOPROPYNYL BUTYLCARBAMATE, A PRESERVATIVE FOUND IN A LOT OF MEDICAL SUPPLIES AND EQUIPMENT. IT CAUSES WATER BLISTERS, SEVERE REDNESS AND INFLAMMATION, BURNING AND CONSTANT PAIN/SKIN SENSIBILITY. THE CAMERA NORMALLY PASSES THROUGH THE DIGESTIVE TRACK AFTER 12 HOURS. IN MY CASE IT REMAINED IN MY INTESTINES OVER 16 DAYS, REVEALED IN AN X-RAY ON (B)(6) 2022. I EXPERIENCED SEVERE DIARRHEA AND STOMACH PAIN FOR OVER 3 WEEKS. ON (B)(6) 2022 THE BURNING AND PAIN BECAME SO SEVERE THAT I WENT TO THE EMERGENCY ROOM. AN X-RAY THIS DATE REVEALED THE CAPSULE WAS NO LONGER IN MY BODY; IT PASSED SOMETIME BETWEEN (B)(6) 2022. I CALLED OLYMPUS, (B)(4), AND SPOKE TO THE TECHNICAL DIVISION, AM (B)(6) 2022. I WAS TOLD THEY WOULD NOT RELEASE THE INGREDIENTS TO ME, THE PATIENT. THE INFORMATION COULD ONLY BE PROVIDED TO THE DOCTOR. I CALLED MY DOCTOR'S OFFICE AND REQUESTED MY DOCTOR CALL OLYMPUS. AT THE EMERGENCY ROOM I REQUESTED THEIR PERSONNEL CALL OLYMPUS; THEY REFUSED TO MAKE THE CALL. I CALLED OLYMPUS FROM THE HOSPITAL AND REQUESTED THEY MERELY CONFIRM OR DENY THAT THE CAPSULE COATING CONTAINED THE PRESERVATIVE. OLYMPUS REFUSED TO PROVIDE ANY INFORMATION TO HOSPITAL PERSONNEL, STATING PROPRIETARY REASONS AND THEY HAD TO SEND THE REQUEST TO (B)(4); I LEARNED LATER YESTERDAY THAT DR (B)(6) HAD ALREADY CALLED OLYMPUS TWICE AND WAS DENIED ACCESS TO THE INGREDIENTS IN THE CAPSULE. I HAVE BEEN ADVISED THAT DR. (B)(6) FILED AN FDA REPORT. BASED ON THE SYMPTOMS I AM HAVING, I AM 90% SURE THAT THE LINING OF MY INTESTINES/COLON IS EXPERIENCING THE SAME SYMPTOMS I HAVE EXPERIENCED ON MY SKIN. MY STOMACH FEELS RAW; MY STOMACH IS BURNING AND HURTING SEVERELY AND CONSTANTLY. THE ALLERGIC REACTION HAS BEEN TREATED WITH TYPICAL OINTMENTS, I.E. BETAMETHASONE, IN THE PAST. MY LAST EPISODE, FALL 2021, WAS FROM A METAL SPLINT ON MY RING FINGER, LEFT HAND, DUE A TORN TENDON. IT TOOK FIVE (5) MONTHS FOR THE SKIN TO HEAL. IN (B)(6) 2019, AT (B)(6), LUNG SURGERY, I HAD BACK SORES FROM 3M SURGICAL TAPE; I STILL HAVE MARKS ON MY BACK FROM THE 10 DAY USE (IN THE HOSPITAL) OF THE TAPE. THE TAPE CONTAINS THE PRESERVATIVE. I CANNOT BE TREATED UNTIL IT IS DETERMINED WHETHER OR NOT THE PRESERVATIVE IS THE CAUSE. I AM WRITING TO REQUEST (BEGGING) FOR YOUR ASSISTANCE IN OBTAINING THE INGREDIENTS IN THE OLYMPUS CAPSULE. THE PRESERVATIVE CAN BE UNDER 10 DIFFERENT NAMES. IT IS IN COSMETICS, BATH CARE PRODUCTS, GROOMING PRODUCTS, PAINTS, PRIMERS, INDUSTRIAL COOLANTS, PESTICIDE, ETC., BESIDES MEDICAL SUPPLIES AND EQUIPMENT. IT WILL PROBABLY TAKE MONTHS OF TREATMENT. CAN YOU HELP ME OBTAIN THE INGREDIENTS IN THE OLYMPUS ENDO CAPSULE? (B)(6) LAND LINE/HOME PHONE. X-RAYS COMPLETED (B)(6) 2022 REVEALED CAPSULE STILL IN DIGESTIVE TRACT X-RAY (B)(6) 2022 REVEALED CAPSULE HAD PASSED. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
392133 OLYMPUS ENDO CAPSULE SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ OLYMPUS CORPORATION OF THE AMERICAS 2021022

Patients

Seq Age Sex Outcome Treatment
1 77 YR Female Other AMBIEN| ARED EYE SUPPLEMENTS| ARICEPT| ASPIRIN| B COMPLEX | B12 INJECTIONS| BUMETANIDE| BYSTOLIC | CELEBREX | CRESTOR | EFFEXOR | ESTRACE CREAM| MELOXICAM | NEXIUM | POTASSIUM| PROBIOTIC CAPS| RESTASIS| SPIRONOLACTONE| SYNTHROID| TRAMADOL ANTIVERT| VIT D| ZANAFLEX