FDA Adverse Event Injury Summary report: N

RESHAPE INTEGRATED DUAL BALLOON SYSTEM

MDR report key: 6274073 · Received January 24, 2017

Report

Report Number
3007934906-2017-00002
Event Type
Injury
Date Received
January 24, 2017
Date of Event
October 30, 2016
Report Date
January 24, 2017
Manufacturer
RESHAPE MEDICAL, INC.
Product Code
LTI
UDI-DI
B001RSM1011
PMA / PMN Number
P140012
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

ON (B)(6) 2016, PATIENT CONTACTED IMPLANTING MD AND COMPLAINED OF WEAKNESS AND RETCHING, BUT DENIED VOMITING. PATIENT DENIED GREEN/BLUE URINE. ON (B)(6) 2016, PATIENT REPORTED HAVING DIFFICULTY WITH SOLID FOODS, BUT WAS ABLE TO TOLERATE PROTEIN SHAKES AND YOGURT. PATIENT ALSO STATED THAT SHE HAD NO VOICE SINCE THE PROCEDURE. PATIENT WAS ADVISED TO STAY ON LIQUIDS OVER THE WEEKEND AND VISIT MD'S OFFICE FOR FOLLOW UP THE NEXT WEEK. THE PATIENT WAS ADVISED THAT IF SHE BEGAN VOMITING TO CALL MD'S OFFICE AND GO TO ER. ON (B)(6) 2016, MD WAS ABLE TO SPEAK DIRECTLY WITH PATIENT. PER MD, SHE WAS VERY WEAK AND HAD DIFFICULTY AMBULATING AND SHORTNESS OF BREATH. MD ADVISED HER TO CALL 911 AND GO TO ER FOR EVALUATION. ON (B)(6) 2016, PATIENT WENT TO ER. PATIENT WAS DIAGNOSED AS HAVING A BILATERAL PULMONARY EMBOLISM AND WAS ANTICOAGULATED WITH HEPARIN. ON (B)(6) 2016, PATIENT WAS REPORTED STABLE AND PLACED ON HEPARIN DRIP, AND THAT PATIENT WOULD BE ADVANCING TO ORAL ANTI-COAGULATION THE NEXT DAY. ON (B)(6) 2016, PATIENT HAD BALLOON REMOVED BY IMPLANTING PHYSICIAN. BALLOON WAS REMOVED ON (B)(6) 2016 AND NO FURTHER SEQUELAE WERE REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
57857 RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON LTI RESHAPE MEDICAL, INC. 01-0011-001 160714-001 B001RSM1011

Patients

Seq Age Sex Outcome Treatment
1 67 YR Hospitalization| O