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 Chest Pain (1776); Unspecified Musculoskeletal problem (4535); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/24/2022

Event Type  Injury  

Event Description

Chest pains [chest pain].Pain between my shoulder blades [musculoskeletal pain].Chest tightness [chest discomfort].Case narrative: this initial spontaneous report was received from the united states of america by health care professional on (b)(6) 2022.A 46-year-adult female patient (weight: 237 lbs) experienced chest pain, chest tightness and interscapular pain while on plenity for an unknown indication.The patient¿s concurrent conditions included: migraines, obstructive sleep apnea; drug allergies and other medical devices usage were not reported.The patient¿s concomitant medication included: zolmitriptan, nurtec odt (rimegepant sulfate).On (b)(6) 2022, the patient started oral therapy with plenity at a dose of 3 capsules, twice daily, 20 to 30 minutes prior to lunch and dinner with 16 oz of water for an unknown indication.The lot number and expiry date of plenity were not reported.On (b)(6) 2022, the patient went to emergency room (er) and then was hospitalized for 2 days with severe chest pains (pt: chest pain), pain between in her shoulder blades (pt: musculoskeletal pain), chest tightness (pt: chest discomfort).After a lot of tests, it was found that her heart was fine, the only thing which was changed recently was that she started taking plenity a week before, hence she stopped taking plenity last week.No treatment medications information was reported.On (b)(6) 2022, the patient was discharged from hospital and the symptoms disappeared after stopping plenity.There was a suspicion that plenity might have contributed to the events.The case was assessed as serious due to the need for hospitalization.Action taken: patient discontinued plenity due to events chest pain, chest discomfort and musculoskeletal pain.Outcome of the events chest pain, chest discomfort and musculoskeletal pain were resolved.This case was verified by a healthcare professional.Company comment: this spontaneous case refers to a 46-year-old female patient who experienced chest pain, chest tightness and pain in between her shoulder blades 3 days after starting plenity for an unknown indication.She visited er and was hospitalized.Further specifics about intervention received and specific diagnostic tests were not provided but it was reported that cardiac causes of chest pain were ruled out.She was discharged 2 days later after her symptoms resolved.Medical history is significant for migraine and obstructive sleep apnea and is on treatment with zolmitriptan and rimegepant.The case is assessed as serious due to the need for hospitalization.Based on the reasonable temporal relationship and spontaneous nature of the report, causality is assessed as possible.More information regarding relevant diagnostic tests and treatment received is required for proper assessment of the case.

• 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: 15379500
• MDR Text Key: 299472046
• Report Number: 3012121187-2022-00963
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2022
• 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: NURTEC ODT (RIMEGEPANT SULFATE),; ZOLMITRIPTAN (ZOLMITRIPTAN),
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 108 KG