| Model Number MC0671 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 06/18/2022 |
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Event Type
Injury
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Event Description
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Pill was stuck in throat [foreign body in throat].Pill expanded in throat [device malfunction].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on (b)(6) 2022.A 56-year-old female patient (weight: 161 lbs) reported medication stuck in throat and device malfunction while on plenity for weight management.The patient¿s initial weight was 164 lbs.The patient¿s medical history, current conditions, drug allergies and usage of other medical devices were not provided.The patient¿s concomitant medications included: synthroid (levothyroxine sodium) 75 mcg once daily, magnesium (magnesium carbonate), vitamin e (tocopheryl acetate) and vitamin b12 (cyanocobalamin).On (b)(6) 2022, the patient started therapy with plenity (lot number: a21280b1, expiration date: 07-apr-2023 and serial number: (b)(4), udi: (b)(4)) at a dose of 3 capsules twice daily 20-30 minutes before lunch and dinner with 16 oz of water for weight management.On (b)(6) 2022, the patient swallowed one capsule fine and second one got stuck in throat (pt: foreign body in throat) and got expanded (pt: device malfunction) and developed choking.The patient drank more water to push the pill down, but it did not work and was taken to the nearest urgent care by her husband.In emergency room, the patient was given a bag to vomit and told to keep trying to cough it up.The patient felt like she was dying and could not breathe, the heimlich maneuver was performed, and a half capsule came up.The patient still felt her throat irritated when she took a deep breath.The patient was sent home from urgent care and headed to the er as her chest began to hurt due to all the coughing.The er checked her throat to make sure there was no obstruction.After a few hours, she was released from the hospital as she was breathing well.The patient plans to visit the ent to have her throat scoped to make sure there is no damage caused to her vocal cords.On an unknown date, the patient discontinued plenity.The patient felt that the events was related to the use of plenity.The case is assessed as serious based on the life-threatening nature of the events requiring heimlich maneuver (intervention) in urgent care.Action taken: patient discontinued plenity due to the events.On (b)(6) 2022, the event foreign body in throat was resolved.This case was verified by a healthcare professional.A medical device complaint had been registered with this report.Company comment: this spontaneous report refers to a 56-year-old female patient who reported medication stuck in throat and device malfunction while on plenity for weight management.The patient swallowed the first capsule and got the second one stuck in the throat which expanded and caused choking, and was then taken to the nearest urgent care.Later, the patient felt like she was dying and could not breathe, and heimlich maneuver was performed (half capsule came up).The patient still felt her throat irritated.She then headed to er as her chest began to hurt due to all the coughing.The case is assessed as serious based on the life-threatening nature of the events requiring heimlich maneuver (intervention) in urgent care.Concomitant medications include: synthroid, magnesium, vitamin e and vitamin b12.Plenity was discontinued and the event foreign body in throat was resolved.Considering the plausible temporal association (events occurred approximately 2 months after start of plenity) and spontaneous nature of the report, the causality for both the events is assessed as possible with plenity.Additional information regarding medical history is required for a meaningful case assessment.
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Event Description
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Pill was stuck in throat [foreign body in throat].Pill expanded in throat [device malfunction].Coughing up gel particles/throwing up gel particles [cough].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on 20-jun-2022 and 22-jun-2022.A 56-year-old female patient (weight: 161 lbs) reported medication stuck in throat, coughing, and device malfunction while on plenity for weight management.The patient¿s initial weight was 164 lbs.The patient has a medical history of hypothyroidism.There were no associated drug allergies or usage of other medical devices.However, she was pretty healthy other than needed to take 10 pounds off.The patient¿s concomitant medications included: synthroid (levothyroxine sodium), magnesium (magnesium carbonate), vitamin e (tocopheryl acetate) and vitamin b12 (cyanocobalamin).On (b)(6) 2022, the patient started therapy with plenity (lot number: a21280b1, expiration date: 07-apr-2023 and serial number: (b)(6), udi: (b)(4) at a dose of 3 capsules twice daily 20-30 minutes before lunch and dinner with 16 oz of water for weight management.On (b)(6) 2022, the patient swallowed one capsule fine and second one got stuck in throat (pt: foreign body in throat) and got expanded (pt: device malfunction) and developed choking.The patient drank more water to push the pill down, but it did not work and was taken to the nearest urgent care by her husband.In emergency room, the patient was in bathroom for most of the time, coughing and throwing up gel particles (pt: cough).The pills had broken in her throat, and she was trying to throw it up, however, she could still breath, but it was hard, as the pill was lodged in the throat.She was given a barf bag to vomit and told to keep trying to cough it up.She drank 3-4 bottles of water, but it was just stuck and kept coughing to the point that it caused headache and backache.The patient felt like she was dying and could not breathe, the heimlich maneuver was performed, and a half capsule came up.The patient still felt her throat irritated when she took a deep breath.The patient was sent home from urgent care and headed to the emergency room as her chest began to hurt due to all the coughing.The emergency room checked her throat to make sure there was no obstruction.After a few hours, she was released from the hospital as she was breathing well.The patient plans to visit the ent to have her throat scoped to make sure there is no damage caused to her vocal cords.On the same day, she took lunch and dinner doses of plenity and then did not take it again.The patient felt that the events was related to the use of plenity; it was the first episode of the event experienced by her; and she did not receive any treatment as well.The event foreign body in throat was recovered.It was reported that the patient did not have any esophageal disorders that could have contributed to the event.The patient reported that her throat was not scoped and had made an appointment with primary care physician in a in a week and half, however, was trying to get it done sooner.The case is assessed as serious based on the life-threatening nature of the events requiring heimlich maneuver (intervention) in urgent care.Action taken: patient discontinued plenity due to the events.Outcome: the event foreign body in throat was resolved and it was unknown whether cough was resolved or not.This case was verified by a healthcare professional.A medical device complaint had been registered with this report.Follow up information received on 28-jun-2022 included: indication of concomitant medication synthroid, details about medical history, drug allergy, medical device usage, information about throat scope, stop date of plenity, information regarding treatment, any contributory factors details were updated, and headache, backache were updated as associated symptoms of the event cough and narrative amended accordingly.Company comment: this spontaneous report refers to a 56-year-old female patient who reported medication stuck in throat, cough and device malfunction while on plenity for weight management.The patient swallowed the first capsule and got the second one stuck in the throat which expanded (device malfunction) and caused choking and was then taken to the nearest urgent care.Later, the patient felt like she was dying and could not breathe, and heimlich maneuver was performed (half capsule came up).The patient still felt her throat irritated and headed to emergency room as her chest began to hurt due to all the coughing.She kept coughing to the point that it caused headache and backache.The case is assessed as serious based on the life-threatening nature of the events requiring heimlich maneuver (intervention) in urgent care.Concomitant medications include: synthroid for hypothyroidism, magnesium, vitamin e and vitamin b12.Plenity was discontinued on the same day and the event foreign body in throat was resolved.Considering the plausible temporal association (events occurred approximately 2 months after start of plenity) and spontaneous nature of the report, the causality for all the events is assessed as possible with plenity.
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Event Description
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Pill was stuck in throat [foreign body in throat] pill expanded in throat [device malfunction] coughing up gel particles/throwing up gel particles [cough].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on 20-jun-2022 and 22-jun-2022.A 56-year-old female patient (weight: 161 lbs) reported medication stuck in throat, coughing, and device malfunction while on plenity for weight management.The patient¿s initial weight was 164 lbs.The patient has a medical history of hypothyroidism.There were no associated drug allergies or usage of other medical devices.However, she was pretty healthy other than needed to take 10 pounds off.The patient¿s concomitant medications included: synthroid (levothyroxine sodium), magnesium (magnesium carbonate), vitamin e (tocopheryl acetate) and vitamin b12 (cyanocobalamin).On (b)(6) 2022, the patient started oral therapy with plenity (lot number: a21280b1, expiration date: 07-apr-2023 and serial number: (b)(6), udi: (b)(4) at a dose of 3 capsules twice daily 20-30 minutes before lunch and dinner with 16 oz of water for weight management.On (b)(6) 2022, the patient swallowed one capsule fine and second one got stuck in throat (pt: foreign body in throat) and got expanded (pt: device malfunction), then she choked and could have died with diet pills.The patient drank more water to push the pill down, but it did not work and was taken to the nearest urgent care by her husband.In emergency room, the patient was in bathroom for most of the time.The pills had broken and open in her throat, and she was trying to throw it up, however, she could still breathe, but it was hard, as the pill was lodged in the throat.She was given a barf bag to vomit and told to keep trying to cough it up.She drank 3-4 bottles of water, but it was just stuck and kept coughing to the point that it caused headache and backache.The patient felt like she was dying and could not breathe, the heimlich maneuver was performed, and a half capsule came up.The patient still felt her throat irritated when she took a deep breath.The patient was sent home from urgent care and headed to the er as her chest began to hurt due to all the coughing.The er checked her throat to make sure there was no obstruction.After a few hours, she was released from the hospital as she was breathing well.It was reported that the patient was coughing and throwing up gel particles (pt: cough) for over 10 days.The patient plans to visit the ent to have her throat scoped to make sure there is no damage caused to her vocal cords.On the same day, she took lunch and dinner doses of plenity and then did not take it again.The patient felt that the events was related to the use of plenity; it was the first episode of the event experienced by her; and she did not receive any treatment as well.The event foreign body in throat was recovered.It was reported that the patient did not have any esophageal disorders that could have contributed to the event.The patient reported that her throat was not scoped and had made an appointment with primary care physician in a in a week and half, however, was trying to get it done sooner.The case is assessed as serious based on the life-threatening nature of the events requiring heimlich maneuver (intervention) in urgent care.Action taken: patient discontinued plenity due to the events.Outcome: the event foreign body in throat was resolved and it was unknown whether cough was resolved or not.This case was verified by a healthcare professional.A medical device complaint had been registered with this report.Follow up information received on 28-jun-2022 included: indication of concomitant medication synthroid, details about medical history, drug allergy, medical device usage, information about throat scope, stop date of plenity, information regarding treatment, any contributory factors details were updated, and headache, backache were updated as associated symptoms of the event cough and narrative amended accordingly.Non-significant follow up information was received on 08-aug-2022 included update on verbatim of the event choking and narrative amended accordingly.Follow up information received on 29-sep-2022 included: the duration of coughing plenity particle was updated.Narrative amended accordingly.Company comment: this spontaneous report refers to a 56-year-old female patient who reported medication stuck in throat, cough and device malfunction while on plenity for weight management.The patient swallowed the first capsule and got the second one stuck in the throat which expanded (device malfunction) and caused choking and was then taken to the nearest urgent care.Later, the patient felt like she was dying and could not breathe, and heimlich maneuver was performed (half capsule came up).The patient still felt her throat irritated and headed to er as her chest began to hurt due to all the coughing.She kept coughing for over ten days which led to headache and backache.The case is assessed as serious based on the life-threatening nature of the events requiring heimlich maneuver (intervention) in urgent care.Concomitant medications include: synthroid for hypothyroidism, magnesium, vitamin e and vitamin b12.Plenity was discontinued on the same day and the event foreign body in throat was resolved.Considering the plausible temporal association (events occurred approximately 2 months after start of plenity) and spontaneous nature of the report, the causality for all the events is assessed as possible with plenity.Follow-up information doesn¿t change the medical assessment of the case.
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Event Description
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Pill was stuck in throat [foreign body in throat].Pill expanded in throat [device malfunction].Coughing up gel particles/throwing up gel particles [cough].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on 20-jun-2022 and 22-jun-2022.A 56-year-old female patient (weight: 161 lbs) reported medication stuck in throat, coughing, and device malfunction while on plenity for weight management.The patient¿s initial weight was 164 lbs.The patient has a medical history of hypothyroidism.There were no associated drug allergies or usage of other medical devices.However, she was pretty healthy other than needed to take 10 pounds off.The patient¿s concomitant medications included: synthroid (levothyroxine sodium), magnesium (magnesium carbonate), vitamin e (tocopheryl acetate) and vitamin b12 (cyanocobalamin).On (b)(6) 2022, the patient started oral therapy with plenity (lot number: a21280b1, expiration date: 07-apr-2023 and serial number: (b)(6), udi: (b)(4) at a dose of 3 capsules twice daily 20-30 minutes before lunch and dinner with 16 oz of water for weight management.On (b)(6) 2022, the patient swallowed one capsule fine and second one got stuck in throat (pt: foreign body in throat) and got expanded (pt: device malfunction), then she choked and could have died with diet pills.The patient drank more water to push the pill down, but it did not work and was taken to the nearest urgent care by her husband.In emergency room, the patient was in bathroom for most of the time.The pills had broken and open in her throat, and she was trying to throw it up, however, she could still breath, but it was hard, as the pill was lodged in the throat.She was given a barf bag to vomit and told to keep trying to cough it up.She drank 3-4 bottles of water, but it was just stuck and kept coughing to the point that it caused headache and backache.The patient felt like she was dying and could not breathe, the heimlich maneuver was performed, and a half capsule came up.The patient still felt her throat irritated when she took a deep breath.She was gagging even worse because of all the watering, coughing, the pills split open and all the little particles that expanded in her stomach were stuck in the throat.The patient was sent home from urgent care and headed to the er as her chest began to hurt due to all the coughing.The er checked her throat to make sure there was no obstruction.After a few hours, she was released from the hospital as she was breathing well.It was reported that the patient was coughing and throwing up gel particles (pt: cough) for about 3 days.The patient plans to visit the ent to have her throat scoped to make sure there is no damage caused to her vocal cords.On the same day, she took lunch and dinner doses of plenity and then did not take it again.The patient felt that the events was related to the use of plenity; it was the first episode of the event experienced by her; and she did not receive any treatment as well.The event foreign body in throat was recovered.It was reported that the patient did not have any esophageal disorders that could have contributed to the event.The patient reported that her throat was not scoped and had made an appointment with primary care physician in a in a week and half, however, was trying to get it done sooner.The case is assessed as serious based on the life-threatening nature of the events requiring heimlich maneuver (intervention) in urgent care.Action taken: patient discontinued plenity due to the events.Outcome: the event foreign body in throat was resolved and it was unknown whether cough was resolved or not.This case was verified by a healthcare professional.A medical device complaint had been registered with this report.Follow up information received on 28-jun-2022 included: indication of concomitant medication synthroid, details about medical history, drug allergy, medical device usage, information about throat scope, stop date of plenity, information regarding treatment, any contributory factors details were updated, and headache, backache were updated as associated symptoms of the event cough and narrative amended accordingly.Non-significant follow up information was received on 08-aug-2022 included update on verbatim of the event choking and narrative amended accordingly.Follow up information received on 29-sep-2022 included: the duration of coughing plenity particle was updated.Narrative amended accordingly.Follow up information received on 08-dec-2022 included: additional associated symptom was updated and narrative was modified.Company comment: this spontaneous report refers to a 56-year-old female patient who reported medication stuck in throat, cough and device malfunction while on plenity for weight management.The patient swallowed the first capsule and got the second one stuck in the throat which expanded (device malfunction) and caused choking and was then taken to the nearest urgent care.Later, the patient felt like she was dying and could not breathe, and heimlich maneuver was performed (half capsule came up).The patient still felt her throat irritated and was even gagging.She then headed to er as her chest began to hurt due to all the coughing.She kept coughing and throwing up gel particles for over three days which led to headache and backache.The case is assessed as serious based on the life-threatening nature of the events requiring heimlich maneuver (intervention) in urgent care.Concomitant medications include: synthroid for hypothyroidism, magnesium, vitamin e and vitamin b12.Plenity was discontinued on the same day and the event foreign body in throat was resolved.Considering the plausible temporal association (events occurred approximately 2 months after start of plenity) and spontaneous nature of the report, the causality for all the events is assessed as possible with plenity.Follow-up information doesn¿t change the medical assessment of the case.
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Search Alerts/Recalls
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