| Model Number MC0420 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Hernia (2240); Constipation (3274); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
| Event Date 07/20/2022 |
|
Event Type
Injury
|
|
Event Description
|
|
Abdominal pain [abdominal pain].Patient have so much feces in her colon.She couldn't get it out/ constipation [constipation].Colitis [colitis].Hernia [hernia].Diarrhea [diarrhoea].The patient had gained weight of 5 lbs [weight increased].The patient had gained weight of 5 lbs [device ineffective].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on 14-sep-2022, 15-sep-2022 and 20-sep-2022.A 49-year-adult female patient (weight 225 lbs) reported diarrhea, abdominal pain, constipation, colitis, hernia, device ineffective and weight gain while on plenity for weight management.The patient¿s initial weight was 220 lbs; current conditions included: ibs (irritable bowel syndrome) for past 20 years, anxiety; procedure included gallbladder removal surgery in 2009; medical history, drug allergies and usage of other medical devices were not provided.The patient¿s concomitant medications included: seroquel (quetiapine fumarate), oxybutynin (oxybutynin hydrochloride) and zoloft (sertraline hydrochloride).On (b)(6) 2022, the patient started therapy with plenity (lot number: a22012b1; expiry date: 12-jul- 2023; udi number: (b)(4), which was obtained from hcp through gogo meds (first box) and second box through ro, at a dose of 3 capsules, twice daily, before lunch and dinner with 3 or 4 glasses of water for weight management and also followed the exercise regimen.On (b)(6) 2022, after taking plenity at that same time, she developed diarrhea (pt: diarrhoea).On (b)(6) 2022, after 2 weeks of taking plenity the patient experienced abdominal pain (pt: abdominal pain) and constipation (pt: constipation).The patient consulted with her hcp, who advised her to keep taking plenity.However, she experienced abdominal pain and constipation despite of taking plenity continuously throughout (b)(6) 2022.On (b)(6) 2022, the patient reported that she had a hernia (pt: hernia) and on the same day, she took last dose of plenity and stopped it.On (b)(6) 2022, the patient went to the emergency room (er) for abdominal pain and constipation and received treatment with iv pain medications and toradol for abdominal pain.The constipation was treated with salt water.On the same day, she was admitted in the hospital with colitis (pt: colitis) and hernia.She was having a painful time and could not walk at all and was given pain relief.She had so many feces in her colon, she couldn¿t get them out for which she drank the gi drink to treat constipation, however, the feces were still in her colon.The patient stated that she couldn¿t eat anymore and felt fine with ibs (irritable bowel syndrome) on and off.On (b)(6) 2022, the patient was notified that she had a hernia, for which she was advised to treat with a liquid diet and rest and on the same day the patient was discharged from the hospital.The patient reported that she had gained weight of 5 lbs (pt: weight increased and device ineffective).She thought all the events are related to plenity and other factors might be associated with the events and also raised a question as she wanted to know what she need to do with the lot of left over plenity boxes.Besides taking plenity, the patient was following an exercise regimen.Action taken: patient discontinued plenity due to events diarrhoea, abdominal pain, constipation, colitis, hernia and weight increased.This case is assessed as serious given the need for hospitalization for the events constipation, abdominal pain, colitis, and hernia.Outcome of events diarrhea, abdominal pain and constipation were resolved, and outcome of events hernia and weight increased were not resolved and outcome of event colitis was unknown.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 49-year-old adult female patient who reported diarrhea, hernia, colitis, abdominal pain, constipation, device ineffective and weight gain while on plenity for weight management.Current conditions included: ibs, anxiety; procedure included gallbladder removal surgery and concomitant medications included: seroquel, oxybutynin and zoloft.The patient developed diarrhea on the same day of starting plenity therapy and two weeks later patient also started experiencing abdominal pain and constipation.She consulted the hcp who advised her to continue plenity and patient continued despite having abdominal pain and constipation.Patient discontinued plenity approximately one month later.She was diagnosed with hernia on the same day.Three days after discontinuation patient went to the er for abdominal pain and constipation, where she was admitted with diagnosis of colitis and hernia and given i.V pain medications and toradol for pain and salt water for constipation.She was discharged the next day and was advised to treat the hernia with rest and liquid diet.The patient also reported that she had gained 5 lbs.The events abdominal pain, constipation and diarrhea were reported as resolved.This case is assessed as serious given the need for hospitalization for the events constipation, abdominal pain, colitis, and hernia.Based on the reasonable temporal relationship, and spontaneous nature of the report, causality is assessed as possible for the events diarrhea, colitis, hernia, abdominal pain, constipation, and weight gain.The causality for the event device ineffective is assessed as not applicable as it is regarded as a special situation.
|
| |
|
Event Description
|
|
Colitis/colon was very inflamed, they call it angry colon where it gets really red and inflamed [colitis].Ibs flare up [irritable bowel syndrome].The patient had gained weight of 5 lbs [weight increased].Colon was full of black spots [gastrointestinal tract mucosal pigmentation].Feces stuck in the colon [faecaloma].The patient had gained weight of 5 lbs [device ineffective].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on 14-sep-2022, 15-sep-2022 and 20-sep-2022.A 49-year-adult female patient (weight 225 lbs) reported colitis, irritable bowel syndrome aggravated, pigmentation of colon mucosa, fecal impaction, weight gain and device ineffective while on plenity for weight management.The patient¿s initial weight was 220 lbs; current conditions included: ibs (irritable bowel syndrome) constipation predominant for past 20 years, anxiety, chronic constipation ; procedure included gallbladder removal surgery in 2009; medical history, drug allergies and usage of other medical devices were not provided.The patient¿s concomitant medications included: seroquel (quetiapine fumarate), oxybutynin (oxybutynin hydrochloride), zoloft (sertraline hydrochloride) and miralax (macrogol 3350).On (b)(6) 2022, the patient started therapy with plenity (lot number: a22012b1; expiry date: 12-jul-2023; udi number: (b)(4), which was obtained from hcp through gogo meds (first box) and second box through ro, at a dose of 3 capsules, twice daily, before lunch and dinner with 3 or 4 glasses of water for weight management and also followed the exercise regimen.The patient took the pills for 2 months.On (b)(6) 2022, after taking plenity at that same time, she experienced very little diarrhea and felt that it was the primary cause of constipation.On (b)(6) 2022, after 2 weeks of taking plenity, the patient experienced bad cramps, abdominal pain and constipation.The patient consulted with her hcp, who advised her to keep taking plenity.However, she experienced abdominal pain and constipation despite of taking plenity continuously throughout aug-2022.On (b)(6) 2022, the patient had recovered from the event diarrhea.On (b)(6) 2022, the patient reported that she had a hernia and on the same day, she took last dose of plenity and stopped it.On (b)(6) 2022, the patient went to the emergency room (er) for abdominal pain and constipation and received treatment with iv pain medications and toradol for abdominal pain.The constipation was treated with salt water.On the same day, she was admitted in the hospital with red and inflamed colon (pt: colitis) and hernia.She was having a painful time and could not walk at all and was given fentanyl and trazodone.The patient was given motegrity to relieve constipation, which she continued, and she tried an enema, which failed.She also took miralax on a daily basis.Before starting plenity, the patient was taking miralax.She had so many feces in her colon, she couldn¿t get them out for which she drank the gi drink to treat constipation, however, the feces were still in her colon and got stuck and severely backed up (pt: faecaloma).It was reported that, feces could not evacuate the colon and had to drink barium and water.She stated that reason for her hospitalization was constipation as it was the leading problem.A computed tomography (ct) scan and magnetic resonance imaging (mri) with and without liquid were performed, and it was revealed that the colon was full of black spots (pt: gastrointestinal tract mucosal pigmentation) and was diagnosed with colitis.She was advised to avoid sugar products, drink plenty of water.On (b)(6) 2022, the patient was notified that she had a hernia, for which she was advised to treat with a liquid diet and rest and on the same day the patient was discharged from the hospital.On (b)(6) 2022, the patient had recovered from the event constipation.On (b)(6) 2022, she was informed that it was not a hernia and she thought that they made a mistake while looking for what was causing the pain and her colon was upset and full of feces.On (b)(6) 2022, the patient had recovered from the event colitis.She was feeling much better and decided not to take plenity because it would exacerbate her symptoms.The patient stated that she was unable to eat and that her ibs (irritable bowel syndrome) was not stable prior to plenity, and thought that the symptoms abdominal pain, constipation and diarrhea were a flare-up of ibs (pt: irritable bowel syndrome).The patient reported that she had gained weight of 5 lbs (pt: weight increased and device ineffective).She thought colitis, weight increased, gastrointestinal tract mucosal pigmentation and faecaloma are related to plenity and other factors might be associated with the events and also raised a question as she wanted to know what she need to do with the lot of left over plenity boxes.The patient felt that it was her mistake to take plenity because of chronic constipation.Action taken: patient discontinued plenity due to events irritable bowel syndrome, colitis, weight increased, gastrointestinal tract mucosal pigmentation and faecaloma.This case is assessed as serious given the need for hospitalization for the events ibs and colitis.Outcome of event colitis was resolved, and outcome of event weight increased were not resolved and outcome of the events irritable bowel syndrome, gastrointestinal tract mucosal pigmentation and faecaloma were unknown.This case was verified by a healthcare professional.A medical device complaint had been registered with this report.Follow up information received on 30-sep-2022 and included: medical history (chronic constipation and ibs constipation predominant), concomitant medication (miralax), events gastrointestinal tract mucosal pigmentation, irritable bowel syndrome and faecaloma updated.Outcome and stop date of the event colitis was updated.Narrative was amended accordingly.Company comment: this spontaneous report refers to a 49-year-old adult female patient who reported ibs (irritable bowel syndrome), colitis, faecaloma, gastrointestinal tract mucosal pigmentation, device ineffective and weight gain while on plenity for weight management.Current conditions included: ibs (constipation predominant), chronic constipation, and anxiety; procedure included gallbladder removal surgery and concomitant medications included: seroquel, oxybutynin, miralax and zoloft.The patient developed diarrhea on the same day of starting plenity therapy and two weeks later experienced abdominal pain, bad cramps and constipation.She consulted the hcp who advised her to continue plenity and patient continued despite having abdominal pain and constipation.Patient discontinued plenity approximately one month later.Three days after discontinuation, patient went to the er for abdominal pain and constipation and was given i.V pain medications (fentanyl, toradol and trazodone) and salt water for constipation.On the same day, she was admitted in the hospital with red and inflamed colon and was given motegrity to relieve constipation, and an enema (which failed); and also took miralax daily.She had so many feces in colon and couldn¿t get them out for which she drank the gi drink, however, the feces were stuck and severely backed up.It was reported that, feces could not evacuate the colon and had to drink barium and water.Ct and mri revealed colon full of black spots and was diagnosed with colitis.The patient also reported that she had gained 5 lbs.The patient stated that she was unable to eat and that her ibs was not stable prior to plenity, and thought that the symptoms abdominal pain, constipation and diarrhea were a flare-up of ibs.The event colitis was resolved.This case is assessed as serious given the need for hospitalization for the events ibs and colitis.Based on the reasonable temporal relationship, medical history of ibs and chronic constipation (confounders) and spontaneous nature of the report, causality is assessed as possible for the events ibs, colitis, faecaloma, gastrointestinal tract mucosal pigmentation, and weight gain.The causality for the event device ineffective is assessed as not applicable as it is regarded as a special situation.
|
| |
|
Event Description
|
|
Colitis/colon was very inflamed, they call it angry colon where it gets really red and inflamed [colitis].Ibs flare up [irritable bowel syndrome].The patient had gained weight of 5 lbs [weight increased] colon was full of black spots [gastrointestinal tract mucosal pigmentation] feces stuck in the colon [faecaloma] they are stuck inside my colon [foreign body in gastrointestinal tract] very painful to pass pills [dyschezia] the patient had gained weight of 5 lbs [device ineffective].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on 14-sep-2022, 15-sep-2022 and 20-sep-2022.A 49-year-adult female patient (weight 225 lbs) reported colitis, irritable bowel syndrome aggravated, pigmentation of colon mucosa, fecal impaction, weight gain, foreign body in gastrointestinal tract, painful defecation and device ineffective while on plenity for weight management.The patient¿s initial weight was 220 lbs; current conditions included: ibs (irritable bowel syndrome) constipation predominant for past 20 years, anxiety, chronic constipation; procedure included gallbladder removal surgery in 2009; medical history, drug allergies and usage of other medical devices were not provided.The patient¿s concomitant medications included: seroquel (quetiapine fumarate), oxybutynin (oxybutynin hydrochloride), zoloft (sertraline hydrochloride) and miralax (macrogol 3350).On (b)(6) 2022, the patient started therapy with plenity (lot number: a22012b1; expiry date: 12-jul-2023; udi number: (b)(4) , which was obtained from hcp through gogo meds (first box) and second box through ro, at a dose of 3 capsules, twice daily, before lunch and dinner with 3 or 4 glasses of water for weight management and also followed the exercise regimen.The patient took the pills for 2 months.On (b)(6) 2022, after taking plenity at that same time, she experienced very little diarrhea and felt that it was the primary cause of constipation.On (b)(6) 2022, after 2 weeks of taking plenity, the patient experienced bad cramps, abdominal pain and constipation.The patient consulted with her hcp, who advised her to keep taking plenity.However, she experienced abdominal pain and constipation despite of taking plenity continuously throughout (b)(6) 2022.On (b)(6) 2022, the patient had recovered from the event diarrhea.On (b)(6) 2022, the patient reported that she had a hernia and on the same day, she took last dose of plenity and stopped it.On (b)(6) 2022, the patient went to the emergency room (er) for abdominal pain and constipation and received treatment with iv pain medications and toradol for abdominal pain.The constipation was treated with salt water.On the same day, she was admitted in the hospital with red and inflamed colon (pt: colitis) and hernia.She was having a painful time and could not walk at all and was given fentanyl and trazodone.The patient was given motegrity to relieve constipation, which she continued, and she tried an enema, which failed.She also took miralax on a daily basis.Before starting plenity, the patient was taking miralax.She had so many feces in her colon, she couldn¿t get them out for which she drank the gi drink to treat constipation, however, the feces were still in her colon and got stuck and severely backed up (pt: faecaloma).It was reported that, feces could not evacuate the colon and had to drink barium and water.She stated that reason for her hospitalization was constipation as it was the leading problem.A computed tomography (ct) scan and magnetic resonance imaging (mri) with and without liquid were performed, and it was revealed that the colon was full of black spots (pt: gastrointestinal tract mucosal pigmentation) and was diagnosed with colitis.She was advised to avoid sugar products, drink plenty of water.On (b)(6) 2022, the patient was notified that she had a hernia, for which she was advised to treat with a liquid diet and rest and on the same day the patient was discharged from the hospital.On (b)(6) 2022, the patient had recovered from the event constipation.On (b)(6) 2022, she was informed that it was not a hernia and she thought that they made a mistake while looking for what was causing the pain and her colon was upset and full of feces.On (b)(6) 2022, the patient had recovered from the event colitis.She was feeling much better and decided not to take plenity because it would exacerbate her symptoms.The patient stated that she was unable to eat and that her ibs (irritable bowel syndrome) was not stable prior to plenity, and thought that the symptoms abdominal pain, constipation and diarrhea were a flare-up of ibs (pt: irritable bowel syndrome).The patient reported that she had gained weight of 5 lbs (pt: weight increased and device ineffective).She thought colitis, weight increased, gastrointestinal tract mucosal pigmentation and faecaloma are related to plenity and other factors might be associated with the events and also raised a question as she wanted to know what she need to do with the lot of left over plenity boxes.The patient felt that it was her mistake to take plenity because of chronic constipation and she will no longer take plenity because she felt the pills are stuck inside her colon (pt: foreign body in gastrointestinal tract) and was very painful to pass the pills (pt: dyschezia).She stated that before allowing doctors to prescribe plenity, one should be cautious and look at if they have ibs.Action taken: patient discontinued plenity due to events irritable bowel syndrome, colitis, weight increased, gastrointestinal tract mucosal pigmentation, faecaloma.Foreign body in gastrointestinal tract and dyschezia.This case is assessed as serious given the need for hospitalization for the events ibs and colitis.Outcome of event colitis was resolved, and outcome of event weight increased were not resolved and outcome of the events irritable bowel syndrome, gastrointestinal tract mucosal pigmentation, faecaloma, foreign body in gastrointestinal tract and dyschezia were unknown.This case was verified by a healthcare professional.A medical device complaint had been registered with this report.Follow up information received on 30-sep-2022 and included: medical history (chronic constipation and ibs constipation predominant), concomitant medication (miralax), events gastrointestinal tract mucosal pigmentation, irritable bowel syndrome and faecaloma updated.Outcome and stop date of the event colitis was updated.Narrative was amended accordingly.Follow up information received on 09-oct-2022 and included: additional events foreign body in gastrointestinal tract and dyschezia were added.Narrative was amended accordingly.Company comment: this spontaneous report refers to a 49-year-old adult female patient who reported ibs (irritable bowel syndrome), colitis, faecaloma, gastrointestinal tract mucosal pigmentation, device ineffective, foreign body in gastrointestinal tract, dyschezia and weight gain while on plenity for weight management.Current conditions included: ibs (constipation predominant), chronic constipation, and anxiety; procedure included gallbladder removal surgery and concomitant medications included: seroquel, oxybutynin, miralax and zoloft.The patient developed diarrhea on the same day of starting plenity therapy and two weeks later experienced abdominal pain, bad cramps and constipation.She consulted the hcp who advised her to continue plenity and patient continued despite having abdominal pain and constipation.Patient discontinued plenity approximately one month later.Three days after discontinuation, patient went to the er for abdominal pain and constipation and was given i.V pain medications (fentanyl, toradol and trazodone) and salt water for constipation.On the same day, she was admitted in the hospital with red and inflamed colon and was given motegrity to relieve constipation, and an enema (which failed); and also took miralax daily.She had so many feces in colon and couldn¿t get them out for which she drank the gi drink, however, the feces were stuck and severely backed up.It was reported that, feces could not evacuate the colon and had to drink barium and water.Ct and mri revealed colon full of black spots and was diagnosed with colitis.The patient also reported that she had gained 5 lbs.The patient stated that she was unable to eat and that her ibs was not stable prior to plenity, and thought that the symptoms abdominal pain, constipation and diarrhea were a flare-up of ibs.The patient felt that it was her mistake to take plenity because of chronic constipation and she will no longer take plenity because she felt the pills are stuck inside her colon and was very painful to pass the pills.The event colitis was resolved.This case is assessed as serious given the need for hospitalization for the events ibs and colitis.Based on the reasonable temporal relationship, medical history of ibs and chronic constipation (confounders) and spontaneous nature of the report, causality is assessed as possible for the events ibs, colitis, faecaloma, gastrointestinal tract mucosal pigmentation, foreign body in gastrointestinal tract, dyschezia and weight gain.The causality for the event device ineffective is assessed as not applicable as it is regarded as a special situation.
|
| |
|
Search Alerts/Recalls
|
|
