| Model Number MC0420 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Hypersensitivity/Allergic reaction (1907); Rash (2033); Anaphylactoid (2218)
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| Event Date 11/10/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Product is not retrievable.
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Event Description
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Anaphylaxis [anaphylactic reaction].3 capsules, po, 1 time daily [wrong technique in device usage process].Case narrative: this is a spontaneous report, received from the united states of america initially reported by a physician on 12-nov-2020.A (b)(6) female patient of weight (b)(6) lbs experienced anaphylactic reaction while on plenity for obesity.The patient¿s medical history was not reported.The patient¿s concomitant medications included celexa (citalopram hydrobromide) (20mg daily), irbesartan (12.5 mg daily) for unknown indication.On an unknown date, the patient started therapy with plenity at a dose of three capsules by mouth once daily (wrong technique in device usage process) for obesity.The lot number included p20114a and expiry date 23-oct-2021.On 10-nov-2020, it was reported that the patient went to emergency department due to severe rash on face and was diagnosed with anaphylaxis (pt: anaphylactic reaction).The patient was treated with epinephrine and steroids (unspecified) and was admitted to intensive care unit (icu).It was reported that the patient was seen by the physician due to the concern of viral infection but was determined the event as allergic reaction.It was reported that the physician thought the allergic reaction was most likely due to celexa 20 mg/daily, which the patient daily administered along with the plenity at same time.The diagnostic tests were not carried out for the event.At the time of this report, therapy with the plenity was discontinued and outcome for the event (anaphylactic reaction) was resolved.The patient would be discharged on (b)(6) 2020 (reported as today).This case was verified by a healthcare professional.Company comment: this spontaneous report by a physician concerns a (b)(6) female weighing (b)(6) lbs who was diagnosed with anaphylactic reaction while on plenity for obesity.The patient¿s medical history was not reported but included taking medications celexa (citalopram) (20mg daily), irbesartan (12.5 mg daily) for unknown indications.On an unknown date, the patient started therapy with plenity at a dose of three capsules by mouth once daily (pt: wrong technique in device usage process) for obesity; around the same time, patient is reported to have started treatment with celexa (citalopram).After an unknown period since plenity and citalopram administration, patient presented to the emergency department with severe rash on face and was diagnosed with anaphylaxis (pt: anaphylactic reaction) which was treated with epinephrine and steroids (unspecified).Patient was admitted in the intensive care unit (icu) where she was seen by an infectious disease physician for concerns of viral infection which was ruled out and a diagnosis of anaphylactic reaction was established.The physicians suspected that the allergic reaction was most likely due to celexa (citalopram) which the patient took concurrently with plenity.At the time of this report, therapy with the plenity was discontinued and the event (anaphylactic reaction) was resolved and patient was planned for a discharge on (b)(6) 2020.The event anaphylactic reaction was assessed as serious as it required hospitalization.The case lacks details on medical history, dechallenge and rechallenge; nevertheless, due to the plausible temporal relationship, causality was assessed as possibly related to plenity.Nonetheless, celexa (citalopram) is a strong confounder in this case, in alignment with the hospital physician assessment and the fact that anaphylaxis has been observed during the post marketing evaluation of celexa (citalopram).
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Event Description
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Anaphylaxis [anaphylactic reaction].3 capsules, po, 1 time daily [wrong technique in device usage process].Case narrative: this is a spontaneous report, received from the united states of america initially reported by a physician on (b)(6) 2020.A 54-year-old female patient of weight 160 lbs experienced anaphylactic reaction while on plenity for obesity.The patient¿s medical history was not reported.The patient¿s concomitant medications included celexa (citalopram hydrobromide) (20mg daily), irbesartan (12.5 mg daily) for unknown indication.On an unknown date, the patient started therapy with plenity at a dose of three capsules by mouth once daily (wrong technique in device usage process) for obesity.The lot number included p20114a and expiry date 23-oct-2021.On (b)(6) 2020, it was reported that the patient went to emergency department due to severe rash on face and was diagnosed with anaphylaxis (pt: anaphylactic reaction).The patient was treated with epinephrine and steroids (unspecified) and was admitted to intensive care unit (icu).It was reported that the patient was seen by the physician due to the concern of viral infection but was determined the event as allergic reaction.It was reported that the physician thought the allergic reaction was most likely due to celexa 20 mg/daily, which the patient daily administered along with the plenity at same time.The diagnostic tests were not carried out for the event.At the time of this report, therapy with the plenity was discontinued and outcome for the event (anaphylactic reaction) was resolved.The patient would be discharged on (b)(6) 2020 (reported as today).This case was verified by a healthcare professional.On 24-nov-2020, investigation was performed for the semi-finished product of lot p20114.Gelesis p20114 was produced in apr-2020.As investigation, the in-process records were evaluated for the lot p20114.As per the investigation, the batch record review confirmed that there were no deviations, nor out-of-trends from standard processing.The environmental monitoring records and the qc test records from incoming raw materials to finished product were evaluated, evidencing no out-of-specs against the established acceptance criteria.Full traceability of the referenced lot dhr (device history record) was available.Based on the evaluation, it was concluded that the results of the investigation indicated that gelesis srl lot p20114 was produced, released and met all the quality criteria.On 30-nov-2020, investigation was performed for the finished product of lot p20114a.Review of gelesis inc dhr showed no deviations or non-conformances associated with the production of the lot p20114a.The lot p20114a was released upon evidence of having met all specifications.Device investigation summary report was received on 30-nov-2020: investigation results were updated in respective fields and in the narrative.Company comment: this spontaneous report by a physician concerns a 54-year-old female weighing 160 lbs who was diagnosed with anaphylactic reaction while on plenity for obesity.The patient¿s medical history was not reported but included taking medications celexa (citalopram) (20mg daily), irbesartan (12.5 mg daily) for unknown indications.On an unknown date, the patient started therapy with plenity at a dose of three capsules by mouth once daily (pt: wrong technique in device usage process) for obesity; around the same time, patient is reported to have started treatment with celexa (citalopram).After an unknown period since plenity and citalopram administration, patient presented to the emergency department with severe rash on face and was diagnosed with anaphylaxis (pt: anaphylactic reaction) which was treated with epinephrine and steroids (unspecified).Patient was admitted in the intensive care unit (icu) where she was seen by an infectious disease physician for concerns of viral infection which was ruled out and a diagnosis of anaphylactic reaction was established.The physicians suspected that the allergic reaction was most likely due to celexa (citalopram) which the patient took concurrently with plenity.At the time of this report, therapy with the plenity was discontinued and the event (anaphylactic reaction) was resolved and patient was planned for a discharge on (b)(6) 2020.Product complaint investigation consisted of a quality review of the batch records of the two concerned lots: p20114 (semi-finished product) and p20114a (finished product).All quality measures were met with no issues identified.The event anaphylactic reaction was assessed as serious as it required hospitalization.The case lacks details on medical history, dechallenge and rechallenge; nevertheless, due to the plausible temporal relationship, causality was assessed as possibly related to plenity.Additionally, celexa (citalopram) is a strong confounder in this case, in alignment with the hospital physician assessment and the fact that anaphylaxis has been observed during the post marketing evaluation of celexa (citalopram).
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Event Description
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Anaphylaxis [anaphylactic reaction] 3 capsules, po, 1 time daily [wrong technique in device usage process] case narrative: this is a spontaneous report, received from the united states of america initially reported by a physician on (b)(6) 2020.A 54-year-old female patient of weight 160 lbs experienced anaphylactic reaction while on plenity for obesity.The patient¿s medical history included hypertension and hot flashes.The patient¿s concomitant medications included irbesartan (12.5 mg daily) for hypertension.The patient's co-suspect medications included celexa (citalopram hydrobromide) (20mg, daily, morning, for about a week) for hot flashes.On (b)(6)2020, the patient started therapy with plenity at a dose of three capsules by mouth once daily (wrong technique in device usage process) for obesity.The lot number included p20114a and expiry date (b)(6) 2021.On an unspecified date, the patient experienced the symptoms of itchy burning rash on the head and flu-like symptoms.On (b)(6) 2020, the patient took celexa in the morning, and on the same day, the patient went to the emergency department due to a severe rash on the face and was diagnosed with anaphylaxis (pt: anaphylactic reaction).The time gap between the medication intake and onset of rash was reported as 12-15 hours.The patient confirmed that he did not experience these type of events in the past.The patient was treated with epinephrine and steroids (unspecified) and was admitted to the intensive care unit (icu).The patient had a hypotensive episode once in the hospital.It was reported that the patient was seen by the physician due to the concern of viral infection but was determined the event as an allergic reaction.It was reported that the physician thought the allergic reaction was most likely due to celexa 20 mg/daily, which the patient daily administered along with the plenity at the same time.The diagnostic tests were not carried out for the event.The patient stopped celexa on an unspecified date.The patient also confirmed that anaphylactic reaction occurred after multiple doses of plenity and celexa.At the time of this report, therapy with the plenity was discontinued and the outcome for the event (anaphylactic reaction) was resolved.The patient would be discharged on (b)(6)2020 (reported as today).The case was assessed as serious due to the seriousness criteria hospitalization and intervention required.This case was verified by a healthcare professional.On (b)(6) 2020, an investigation was performed for the semi-finished product of lot p20114.Gelesis p20114 was produced in (b)(6) 2020.As an investigation, the in-process records were evaluated for the lot p20114.As per the investigation, the batch record review confirmed that there were no deviations, nor out-of-trends from standard processing.The environmental monitoring records and the qc test records from incoming raw materials to finished product were evaluated, evidencing no out-of-specs against the established acceptance criteria.Full traceability of the referenced lot dhr (device history record) was available.Based on the evaluation, it was concluded that the results of the investigation indicated that gelesis srl lot p20114 was produced, released, and met all the quality criteria.On (b)(6) 2020, an investigation was performed for the finished product of lot p20114a.A review of gelesis inc dhr showed no deviations or non-conformances associated with the production of the lot p20114a.The lot p20114a was released upon evidence of having met all specifications.Device investigation summary report was received on 30-nov-2020: investigation results were updated in respective fields and in the narrative.Follow-up information received on (b)(6) 2020 included: plenity start date was added ((b)(6) 2020), event symptoms were updated, indication of the concomitant medication irbesartan was added, dosing details of celexa were updated and celexa was updated as co-suspect, and medical history updated.Company comment: this spontaneous report by a physician concerns a 54-year-old female weighing 160 lbs who was diagnosed with anaphylactic reaction, presenting as itchy burning rash, flu like symptoms and a hypotensive episode, approximately a week after initiating plenity for obesity.Patient started to notice rash approximately after 12-15 hours following intake of medications.The patient¿s medical history was significant for hypertension and hot flashes and is being treated concomitantly with irbesartan (12.5 mg daily) and celexa (citalopram) (20mg daily) respectively.She reported taking plenity at a dose of three capsules by mouth once daily (pt: wrong technique in device usage process); around the same time, the patient is reported to have started treatment with celexa (citalopram).She was treated in the emergency department with epinephrine and steroids (unspecified) and was admitted in the intensive care unit (icu) where she was seen by an infectious disease physician for concerns of viral infection which was ruled out and a diagnosis of anaphylactic reaction was established.The physicians suspected that the allergic reaction was most likely due to celexa (citalopram) which the patient took concurrently with plenity.At the time of this report, therapy with the plenity and celexa was discontinued and the event (anaphylactic reaction) was resolved and patient was planned for a discharge on (b)(6)2020.Product complaint investigation consisted of a quality review of the batch records of the two concerned lots: p20114 (semi-finished product) and p20114a (finished product).All quality measures were met with no issues identified.The event anaphylactic reaction was assessed as serious as it required hospitalization.Considering the plausible temporal relationship, causality was assessed as possibly related to plenity.Additionally, celexa (citalopram) is a strong confounder in this case, in alignment with the hospital physician assessment and the fact that anaphylaxis has been observed during the post-marketing evaluation of celexa (citalopram).
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Event Description
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Anaphylaxis [anaphylactic reaction].3 capsules, po, 1 time daily [wrong technique in device usage process].Case narrative: this is a spontaneous report, received from the united states of america initially reported by a physician on (b)(6) 2020.A 54-year-old female patient of weight 160 lbs experienced anaphylactic reaction while on plenity for obesity.The patient¿s medical history included hypertension and hot flashes.The patient had no known food allergies.The patient¿s concomitant medications included irbesartan (12.5 mg daily) for hypertension.The patient's co-suspect medications included celexa (citalopram hydrobromide) (20mg, daily, morning, for about a week) for hot flashes.On (b)(6) 2020, the patient started therapy with plenity at a dose of three capsules by mouth once daily (wrong technique in device usage process) for obesity.The lot number included p20114a and expiry date (b)(6) 2021.On an unspecified date (3-4 days prior to hospital discharge) the patient experienced the symptoms of itchy burning rash on the head and flu-like symptoms on next day.On an unknown date, the patient took celexa in the morning, and on the same day, the patient went to the emergency department due to a severe rash on the face and was diagnosed with anaphylaxis (pt: anaphylactic reaction).The time gap between the medication intake and onset of rash was reported as 12-15 hours.The patient confirmed that he did not experience these type of events in the past.The patient was treated with epinephrine and steroids (unspecified) and was admitted to the intensive care unit (icu).The patient had a hypotensive episode once in the hospital.It was reported that the patient was taking plenity since a week, it was reported that the patient was seen by the physician due to the concern of viral infection but was determined the event as an allergic reaction.It was reported that the physician thought the allergic reaction was most likely due to celexa 20 mg/daily, which the patient daily administered along with the plenity at the same time.The diagnostic tests were not carried out for the event.The patient stopped celexa on an unspecified date.The patient also confirmed that anaphylactic reaction occurred after multiple doses of plenity and celexa and that the last dose of plenity was on the night before patient experienced rash.The patient was discharged on (b)(6) 2020.At the time of this report, therapy with the plenity was discontinued and the outcome for the event (anaphylactic reaction) was resolved.The case was assessed as serious due to the seriousness criteria hospitalization and intervention required.This case was verified by a healthcare professional.On (b)(6) 2020, an investigation was performed for the semi-finished product of lot p20114.Gelesis p20114 was produced in (b)(6) 2020.As an investigation, the in-process records were evaluated for the lot p20114.As per the investigation, the batch record review confirmed that there were no deviations, nor out-of-trends from standard processing.The environmental monitoring records and the qc test records from incoming raw materials to finished product were evaluated, evidencing no out-of-specs against the established acceptance criteria.Full traceability of the referenced lot dhr (device history record) was available.Based on the evaluation, it was concluded that the results of the investigation indicated that gelesis srl lot p20114 was produced, released, and met all the quality criteria.On (b)(6) 2020, an investigation was performed for the finished product of lot p20114a.A review of gelesis inc dhr showed no deviations or non-conformances associated with the production of the lot p20114a.The lot p20114a was released upon evidence of having met all specifications.Device investigation summary report was received on (b)(6) 2020: investigation results were updated in respective fields and in the narrative.Follow-up information received on (b)(6) 2020 included: plenity start date was added ((b)(6) 2020), event symptoms were updated, indication of the concomitant medication irbesartan was added, dosing details of celexa were updated and celexa was updated as co-suspect, and medical history updated.Follow-up information received on (b)(6) 2021 included: hospital discharge date was added ((b)(6) 2020), event start date was updated to unknown (previously reported as (b)(6) 2020).Narrative updated.Company comment: this spontaneous report by a physician concerns a 54-year-old female weighing 160 lbs who was diagnosed with anaphylactic reaction, presenting as itchy burning rash, flu like symptoms and a hypotensive episode, approximately a week after initiating plenity for obesity.Patient started to notice rash approximately after 12-15 hours following intake of medications.She reported taking plenity on the night before she started experiencing symptoms.The patient¿s medical history was significant for hypertension and hot flashes and is being treated concomitantly with irbesartan (12.5 mg daily) and celexa (citalopram) (20mg daily) respectively.She reported taking plenity at a dose of three capsules by mouth once daily (pt: wrong technique in device usage process); around the same time, the patient is reported to have started treatment with celexa (citalopram).She was treated in the emergency department with epinephrine and steroids (unspecified) and was admitted in the intensive care unit (icu) where she was seen by an infectious disease physician for concerns of viral infection which was ruled out and a diagnosis of anaphylactic reaction was established.The physicians suspected that the allergic reaction was most likely due to celexa (citalopram) which the patient took concurrently with plenity.At the time of this report, therapy with the plenity and celexa was discontinued and the event (anaphylactic reaction) was resolved and patient was planned for a discharge on (b)(6) 2020.Product complaint investigation consisted of a quality review of the batch records of the two concerned lots: p20114 (semi-finished product) and p20114a (finished product).All quality measures were met with no issues identified.The event anaphylactic reaction was assessed as serious as it required hospitalization.Considering the plausible temporal relationship, causality was assessed as possibly related to plenity.Additionally, celexa (citalopram) is a strong confounder in this case, in alignment with the hospital physician assessment and the fact that anaphylaxis has been observed during the post-marketing evaluation of celexa (citalopram).
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