MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Distention (2601); Constipation (3274); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/17/2022

Event Type  Injury  

Event Description

Bowel ileus [ileus].Mild nausea [nausea].Spiked temp to 103 [pyrexia].Case narrative: this initial spontaneous report was received from the united states of america on (b)(6) 2022.A 41-year-old female patient (weight: 134 lbs) reported ileus of bowel, nausea and fever while on plenity for weight management.The patient's current medical condition includes hypothyroid.Patient had no allergies.Concomitant medications includes synthroid (levothyroxine sodium) and latisse (bimatoprost).On (b)(6) 2022, the patient started plenity 0.75 gms per capsule/3 capsules, 2 meals twice daily for weight management.The lot number and expiry date of plenity were not reported.On (b)(6) 2022, the patient experienced abdominal distention, trouble moving bowels, mild nausea (pt: nausea).She was passing gas at first and able to keep down liquids, no fever, chills, no pain,no risk factors for small bowel obstruction (sbo).At that time she had only taken 4 doses of plenity as instructed over 2 days.She was monitored for 2 to 4 hours, when her symptoms failed to improve with nothing to eat (npo) except for clear liquids, she was instructed to go to emergency room (er), she did so, but she left without being seen due to long wait.She was followed up by phone visit, she had moving bowels and less distended, low grade temp of 99 at that time.Precaution was given to small bowel obstruction as re ileus.Followed up following day, on (b)(6) 2022, she was still moving bowels but had spiked temp to 103 (pt: pyrexia).Discussed with the patient about risk of bowel obstruction (incarceration, strangulation) and on (b)(6) 2022, advised patient to go to the emergency room.On (b)(6) 2022, she was admitted to the hospital, they did a gastrointestinal (gi) series, confirmed a bowel ileus (pt: ileus).They had given intravenous (iv) fluids to correct electrolyte imbalance.Since then her bowels had returned to pre medication function.On (b)(6) 2022, patient discontinued plenity due to events (ileus, nausea and pyrexia).On(b)(6) 2022, the outcome of the events (ileus, nausea and pyrexia) was resolved.The reporting physician assessed events (ileus, nausea and pyrexia) were probably related to use of plenity.This case is assessed as serious based on the need for hospitalization for the event bowel ileus.This case was verified by a healthcare professional.Company comment: this spontaneous report refers to a 41-year-old female patient who reported ileus, nausea, and fever while on plenity for weight management.Medical history is significant for hypothyroid and concomitant medications included synthroid and latisse.On day 2 of plenity therapy (took only 4 doses of plenity), patient experienced abdominal distention, trouble moving bowels, and mild nausea and plenity was discontinued on the same day.She was monitored for 2 to 4 hours but symptoms failed to improve; so, she went to er but left without being seen due to long wait.Later, patient was followed up by phone, and she reported moving bowels and less distended, and low-grade temp (99).Two days later, she had spiked temp to 103 and was redirected back to er the next day.She was admitted to hospital where a gi series was done and confirmed a bowel ileus.The events resolved after another three days.This case is assessed as serious based on the need for hospitalization for the event bowel ileus.Considering the plausible temporal association, and spontaneous nature of the report, the causality for all the events is assessed as possible with plenity.

• Brand Name: PLENITY
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section D): GELESIS SRL; via verdi, 188; calimera (le) 73021 ; IT 73021
• Manufacturer (Section G): GELESIS, INC.; 501 boylston street, suite 610; 2; boston MA 02116
• Manufacturer Contact: via verdi, 188; calimera (le) 73021
• MDR Report Key: 16144491
• MDR Text Key: 307154649
• Report Number: 3012121187-2023-00001
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• PMA/PMN Number: DEN180060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MC0420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: LATISSE (BIMATOPROST).; SYNTHROID (LEVOTHYROXINE SODIUM).
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 61 KG