MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0420

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/21/2021

Event Type  Injury  

Event Description

Biliary colic along with gall stones [cholelithiasis] case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on (b)(6) 2021.A (b)(6) female patient (weight: (b)(6)) reported cholelithiasis, while on plenity for weight loss.The patient¿s initial weight was (b)(6) and her medical history included: hypertension, pre-diabetes, gallstones, coronary artery disease, biliary colic, arthritis and gallbladder attack less severe occurred 5 years ago.The patient¿s concomitant medications included: metformin (metformin hydrochloride), crestor (rosuvastatin calcium), allegra 180 (fexofenadine hydrochloride), montelukast (montelukast sodium), prilosec (omeprazole), benicar (olmesartan medoxomil), medroxyprogesterone 2.5 (medroxyprogesterone acetate), estradiol 1 mg (estradiol cipionate), valaciclovir 500 mg (valaciclovir hydrochloride), fish oil, vitamin c (ascorbic acid), biotin 5000, zophren (ondansetron), magnesium, citracal (calcium citrate), and hydrocodeine 5325 capsule (as required).The patient¿s medical device usage and drug allergies were not reported.On an unknown date (mid of (b)(6) 2021), the patient started therapy with plenity (lot number: p20339a, expiry: 04-jun-2022, 3 capsules, orally, twice daily for weight loss.On (b)(6) 2021, the patient experienced gallbladder attack after eating fried chicken although the patient did not take plenity on that day.The patient took tylenol ( acetaminophen) at a dose of 1200 mg, 2 tablets at that time for arthritis.On the same day, the patient underwent abdominal ultrasound and abdominal x-ray test and results showed biliary colic along with gall stones (pt: cholelithiasis).On (b)(6) 2021, the patient went to emergency room for gallbladder issue.The patient received treatment with lortab (acetaminophen; hydrocodone) and zofran (ondansetron).It was reported that an unknown lab work was performed, and no abnormal lab results were noted.The event was ongoing and the use of plenity discontinued temporarily.On (b)(6) 2021, the patient consulted a surgeon, suggested for gallbladder removal.The patient lost 10 lbs weight since the start of plenity.The patient felt that the event was related to the use of plenity and made her hcp aware of the event and would follow-up after 2 weeks of surgery.Action taken: patient temporarily discontinued plenity as a result of event (biliary colic due to cholelithiasis).The outcome of the event cholelithiasis was reported as not resolved.This case was verified by a healthcare professional.Follow-up information received on 04-oct-2021 included: medical history, indication of concomitant medications, event start date, diagnostic results, base line weight and current weight updated and narrative amended accordingly.Based on the follow-up information received, the case was assessed as serious as the events necessitated medical/surgical intervention.Company comment: this spontaneous case refers to a (b)(6) female patient who experienced cholelithiasis and biliary colic approximately 3 months after initiating therapy with plenity for weight loss.She visited emergency room the next day where she received supportive treatment and was found to have gall stones on usg abdomen.Surgical removal of gall bladder was suggested by patient's surgeon.It was reported that patient lost 10lbs of weight.Past medical history is significant for similar gall bladder attack 5 years ago which was less severe and current medical conditions include hypertension, pre-diabetes, unspecified allergies and gerd.She is on multiple concomitant medications, hormonal therapy with medroxyprogesterone and estradiol in particular.The case is assessed as serious as the events necessitated medical/surgical intervention (cholecystectomy) to prevent further complications of cholelithiasis and thereby prevent permanent impairment of the body function or structure.The event is considered unlikely related to plenity based on the history of gallbladder attack in the past and presence of obesity, hypertension, pre-diabetes, and hormonal therapy which act as risk factors for cholelithiasis.

• Brand Name: PLENITY
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section D): GELESIS SRL; via verdi, 188; calimera (le) 73021 ; IT 73021
• MDR Report Key: 12712866
• MDR Text Key: 281667674
• Report Number: 3012121187-2021-00367
• 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
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2022
• Device Model Number: MC0420
• Device Lot Number: P20339A
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALLEGRA (FEXOFENADINE HYDROCHLORIDE),; BENICAR (OLMESARTAN MEDOXOMIL),; BIOTIN (BIOTIN),; CITRACAL (CALCIUM CITRATE),; CRESTOR (ROSUVASTATIN CALCIUM),; ESTRADIOL (ESTRADIOL CIPIONATE),; FISH OIL (FISH OIL),; HYDROCODEINE (DIHYDROCODEINE PHOSPHATE),CAPSULE; MAGNESIUM (MAGNESIUM),; MEDROXYPROGESTERONE (MEDROXYPROGESTERONE ACETATE),; METFORMIN (METFORMIN HYDROCHLORIDE),; MONTELUKAST (MONTELUKAST SODIUM),; PRILOSEC (OMEPRAZOLE),; VALACICLOVIR (VALACICLOVIR HYDROCHLORIDE),; VITAMIN C (ASCORBIC ACID),; ZOPHREN (ONDANSETRON),
• Patient Outcome(s): Required Intervention
• Patient Weight: 89