MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0683

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Dizziness (2194)

Event Date 03/23/2022

Event Type  Injury  

Event Description

Possible shrimp allergy [hypersensitivity].Felt fainted [dizziness].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on 24-mar-2022.A (b)(6) female patient (weight: (b)(6)) experienced allergic reaction presenting as shortness of breath, felt faint, itch burning, urticaria, facial swelling, puffy eyes, dark circles under eyes and fever eight days following initiation of plenity for weight loss.The patient's baseline weight: (b)(6).Allergy history included: ongoing allergic to iodine.The patient¿s medical history, concomitant medications, drug allergies, and usage of other medical devices were not provided.On (b)(6) 2022, the patient started oral therapy with plenity (lot number: a71280b1, expiry date: 07-apr-2023, model: mc0683, serial and udi number: (b)(4)) at three capsules, twice daily with 16 oz water 20 mins before lunch and dinner for weight loss.It was reported that, patient ate more vegetables and doing exercise at home, while on plenity.It was reported that, patient generally takes a salad (or) tuna salad (or) chicken salad as her lunch.On (b)(6) -2022 patient only had chicken soup for lunch and taken three plenity capsules with 16 ounces of water around noon then at 12:30 had lunch.On (b)(6) 2022, patient took dinner pills and waited 20 mins or more because of ongoing cooking, then patient took dinner meal (frozen vegetables with rice, sauteed shrimp with garlic, onions, seasoning and soy sauce over the rice).Patient completed dinner meals with more rice and shrimp.It was reported that, patient had eating shrimp for years and never had a problem but it could have been a problem this time.After taking dinner meal within 5 mins or less, patient head started burning and itching (pt: pruritus), felt like lumps in scalp, body was so hot temperature was like 102 (pt: pyrexia).It was reported that, patient bedroom had an attached bathroom, when went through the bedroom to the bathroom face was covered with welts and hives on back, and chest (pt: urticaria).It was reported that, there was no good hospital in the nearest area, patient went into urgent care which is 6 minutes away, by the time got to urgent care, she was not breathing/ shortness of breath (pt: dyspnoea), they immediately given prednisone, a steroid, then they came back and gave another shot (unspecified).By then patient breathing was cleared up on (b)(6) 2022, face and lips was still swollen (pt: swelling face), hives were still on the face, eyes puffy (pt: periorbital swelling), blackness on eyes (pt: dark circles under eyes).Patient stayed in urgent care until felt good, did not felt any shortness of breath and was not faint (pt: dizziness) anymore.On (b)(6) 2022 prednisone and shot were given at urgent care and additional prescription for prednisone 20mgs tablets twice daily for 5 days, and in between they suggested to take a bendryl pill.Urgent care doctor thought that this was more of a shrimp allergy (pt: hypersensitivity) and recommended an allergist.Patient already had iodine allergy history in the past.Patient picked up medicines and went home.Face started clearing up at 1-2 am and stopped itching.Eyes still had puffy and had some blackness around the eye.On (b)(6) 2022, the use of plenity was discontinued.It was reported that, patient decided to discuss about the events to her primary care physician.The case is assessed as serious due to the life threatening nature of the event and urgent medical intervention in the form of prednisone injections.Action taken: patient temporarily discontinued plenity as a result of the events.The outcome of the events (periorbital swelling, dark circles under eyes) was reported as recovering and outcome for remaining events reported as resolved.This case was not verified by a healthcare professional.Company comment: this spontaneous report refers to a (b)(6) female patient who experienced allergic reaction presenting as dyspnea, fainting, pruritus, urticaria, facial swelling, periorbital edema, dark circles under eyes and pyrexia eight days following initiation of plenity for weight loss.Patient reported that on the day of the event, she took dinner dose of plenity and waited a bit longer than 20 minutes before having dinner which included frozen vegetables with rice, sautéed shrimp with garlic, onions, seasoning and soy sauce over the rice.She experienced the symptoms immediately following her dinner and since they were progressing she reached urgent care where she developed dyspnea and was immediately treated with two shots of prednisone.Her symptoms started to improve after a while and was sent home on oral steroids.Urgent care physician suspects shrimp as the likely cause for this allergic reaction.Her medical history is significant for iodine allergy.Although patient reported she never had shrimp allergy she is unsure if there was high iodine in shrimp or if it was due to plenity.She discontinued plenity due to the events.She is due for consultation with her allergist.Concomitant medications are not reported.The case is assessed as serious due to the life threatening nature of the event and urgent medical intervention in the form of prednisone injections.Based on the reasonable temporal relationship, causality is assessed as possible.However, concomitant intake of shrimp acts as a strong confounder.More information regarding concomitant medications, diagnostic evaluation and medical intervention 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: 14135418
• MDR Text Key: 289447713
• Report Number: 3012121187-2022-00048
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN180060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2023
• Device Model Number: MC0683
• Device Lot Number: A71280B1
• Was Device Available for Evaluation?: No
• 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
• Patient Outcome(s): Life Threatening; Other
• Patient Sex: Female
• Patient Weight: 112 KG