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 Hypersensitivity/Allergic reaction (1907)

Event Date 02/05/2021

Event Type  Injury  

Event Description

I had an allergic reaction [hypersensitivity] case narrative.This initial spontaneous report was received from the (b)(6) reported by a physician on (b)(6) 2021.A (b)(6) female patient (weight (b)(6) lbs), experienced an allergic reaction while on plenity for obesity.The patient¿s medical history, current conditions, concomitant medications, and any medical device usage were not reported.On (b)(6) 2021.The patient started therapy with plenity, three capsules, orally, 20 minutes before lunch and dinner for obesity.The lot number and expiry date of plenity were not reported.On the same day, the patient reported that he had a horrible reaction and went to the hospital after the first dose.It was reported that the patient could not swallow or breathe and then the whole body started swelling.The patient developed a rash.The emergency room (er) physician reported that the patient had an allergic reaction (pt: hypersensitivity).The patient was treated with steroids (unspecified medication).After treatment, the patient¿s symptoms disappeared.The physician advised to stop the treatment with plenity and the patient discontinued the treatment.After discontinuation of treatment with plenity, the patient's symptoms disappeared.On (b)(6) 2021, the patient canceled the plenity subscription.Action taken: patient discontinued plenity as a result of the event (allergic reaction).The outcome of the event (allergic reaction) was resolved.The case was assessed as serious due to intervention required.This case was verified by a healthcare professional.Company comment: this initial spontaneous report by a physician concerns a (b)(6) female patient (weight (b)(6) lbs) who experienced an allergic reaction while on plenity for obesity.Medical history, current conditions, concomitant medications, and any medical device usage were not reported.After first dose of plenity, patient had trouble swallowing and breathing, followed by swelling of whole body and generalized rash.Patient immediately went to the emergency room (er) where the physician assessed that the patient had an allergic reaction (pt: hypersensitivity).Patient was treated with steroids (unspecified medication).After treatment and discontinuation of plenity, the symptoms resolved the same day.The physician advised the patient to stop plenity.Considering the systemic nature of symptoms (difficulty in breathing ad swallowing, generalized swelling and rash) and need for treatment with corticosteroid, it appears the nature of symptoms were serious and likely represent an anaphylactic reaction.The case was assessed as serious due to the need for medical intervention (treatment with steroid).Causality to plenity was assessed as possibly related to plenity given the close temporal relationship.

• 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: 11453194
• MDR Text Key: 249232754
• Report Number: 3012121187-2021-00285
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 102