FDA.reportPublic FDA data

MAUDE MDR 5056874

MDR report key
5056874
Report number
3006722112-2015-00327
Event key
0
Event type
3
Date received
2015-09-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LAURA LEBOEUF
Address
1120 S CAPITAL OF TEXAS HWY BULDING 1, SUITE 300 AUSTIN TX 78748 US
Phone
855-855-8555
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ORBERA INTRAGASTRIC BALLOONIMPLANT, INTRAGASTRIC FOR MORBID OBESITYAPOLLO ENDOSURGERYLTIB-50000NIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-09-0401. R

Event Narratives#

N

Patient 1

NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE MODEL NUMBER, SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, EXPLANT DATE, DIAGNOSTIC TESTING, PATIENT DATA OR FURTHER EVENT DETAILS. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF NAUSEA AS FOLLOWS: POSSIBLE COMPLICATIONS OF THE USE OF THE ORBERA? SYSTEM INCLUDE: GASTRIC DISCOMFORT, FEELINGS OF NAUSEA AND VOMITING FOLLOWING BALLOON PLACEMENT AS THE DIGESTIVE SYSTEM ADJUSTS TO THE PRESENCE OF THE BALLOON. CONTINUING NAUSEA AND VOMITING. THIS COULD RESULTS FROM DIRECT IRRITATION OF THE LINING OF THE STOMACH OR AS A RESULT OF THE BALLOON BLOCKING THE OUTLET OF THE STOMACH. IT IS EVEN THEORETICALLY POSSIBLE THAT THE BALLOON COULD PREVENT VOMITING (NOT NAUSEA OR RETCHING) BY BLOCKING THE INLET TO THE STOMACH FROM THE ESOPHAGUS.

D

Patient 1

PATIENT REPORTED "FELT VERY SICK ON 3 FIRST DAYS, USED IV MEDICATIONS," "FEELS BETTER NOW" BUT [PATIENT] "BELIEVES IS LOSING WEIGHT SLOWLY."

N

Patient 1

(B)(4).

D

Patient 1

PATIENT REPORTED "FELT VERY SICK ON 3 FIRST DAYS, USED VONAU (ONDASERTRON), BUSCOPAN (ESCOPOLAMINE) AND PLASIL (METOCLOPRAMIDE), ALL IV. PATIENT "FEELS BETTER NOW" BUT "BELIEVES IS LOSING WEIGHT SLOWLY". DEVICE REMAINS IMPLANTED.