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| Lot Number 0071C4575B |
| Device Problems
Break (1069); Entrapment of Device (1212)
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| Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); Pharyngitis (2367); Foreign Body In Patient (2687)
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| Event Date 05/26/2021 |
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Event Type
Injury
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Manufacturer Narrative
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27-jul-2021, product investigation results: product return was not received.A potentially valid production code has been provided by the reporter, therefore a plant investigation has been started.The associated investigation is still open.Product return was requested and further evaluation may occur if the consumer product is received.
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Event Description
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Interdental brush head encapsulated.Trapped in tonsils, some part of throat [foreign body in throat].Interdental brush head came apart from handle and stuck between two molars [device breakage].Swallowed interdental brush head [exposure via ingestion].Interdental brush came apart during use.Swallowed brush head [accidental device ingestion].Traumatic pharyngitis [pharyngitis].Could feel brush "jabbed" in throat/had feeling of something embedded in throat, tonsils [sensation of foreign body].Pain radiates towards ear [pain].Discomfort of feeling something jabbed in throat [oropharyngeal discomfort].Pain in throat [oropharyngeal pain].Cannot talk because of surgery, entire digestive tract affected [gastrointestinal disorder].Doctor removed mucous [mucosal disorder].A spontaneous report was received via email on 15-jun-2021 from a consumer, unknown gender, age: over 60 years, who used interdental oral-b manual dental floss, beginning on an unspecified date, and swallowed an interdental brush head when it came apart from the handle on an unspecified date.The interdental brush head was trapped in the tonsils for 2 weeks.It was unknown if the consumer had used this version of the product previously and unknown if product use was stopped.The consumer stated that the only solution was to operate on the tonsils (surgery had not yet occurred).The event outcome of foreign body in throat was not recovered/not resolved.The case outcome was not recovered/not resolved.Relevant history: none reported.Concomitant product(s): none reported.No further information was provided.16-jun-2021 received questionnaire: the consumer, a (b)(6) year old female, used the oral-b interdental micro-brush at least once a day, beginning in (b)(6) 2021.On (b)(6) 2021, the brush she was using came apart from the handle, and the interdental brush head became embedded and stuck between two of her molars.When she tried to remove the brush head with her fingers, it was no longer lodged between the teeth because she had swallowed it.She could still feel the discomfort of the brush "jabbed" in her throat and she had the feeling of something embedded in the throat or the tonsils.She had pain that radiated towards her ear, beginning (b)(6) 2021.On (b)(6) 2021, she sought medical attention with an otorhinolaryngologist.She went to the office more than five times, and had been given multiple types of exams like: scanner, x-rays, endoscopies, and introduction of microscopic elements into her throat and esophagus.She was treated with antibiotics and anti-inflammatories, however symptoms persisted.The doctors were considering a possible surgical intervention to remove the tonsils, where they assumed the brush head was encapsulated/lodged in the throat.It was the first time she had used this version of the product, and product use was stopped on (b)(6) 2021.The event outcomes were not recovered/not resolved.The case outcome remained not recovered/not resolved.Relevant history: she had no allergies.She used to use another brand that she never had problems with.No further information was provided.30-jun-2021 follow-up received via phone: the consumer reported that she still had pain in her throat, like there was something sharp in it, beginning 2021.She had been to the doctor and was diagnosed with traumatic pharyngitis, beginning 2021.The doctor told her that if her symptoms did not improve within the week, she would have to undergo surgery.The event outcomes were not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.05-jul-2021 follow-up received via phone: the consumer reported that she would have to have surgery on friday to remove the object.The case outcome remained not recovered/not resolved.No further information was provided.05-jul-2021 case update received: the product was updated to oral-b manual dental floss expert interdental micro interdental no flavor-scent 10 count.The case outcome remained not recovered/not resolved.No further information was provided.12-jul-2021 follow-up received via phone: the husband reported that his wife's entire digestive tract was affected, and she could not talk, from the surgery.The doctor told them he had removed mucous.A consultation was scheduled for (b)(6) 2021 to receive the (surgical) results.The event outcomes of foreign body in throat, sensation of foreign body, pain, pain in throat, oropharyngeal discomfort, pharyngitis, and mucosal disorder were unknown.The event outcome of digestive tract affected/cannot talk was not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.
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Event Description
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Interdental brush head encapsulated.Trapped in tonsils, some part of throat [foreign body in throat] interdental brush head came apart from handle and stuck between two molars [device breakage] swallowed interdental brush head [exposure via ingestion] interdental brush came apart during use.Swallowed brush head [accidental device ingestion] traumatic pharyngitis [pharyngitis] could feel brush "jabbed" in throat/had feeling of something embedded in throat, tonsils [sensation of foreign body] pain radiates towards ear [pain] discomfort of feeling something jabbed in throat/discomfort - throat [oropharyngeal discomfort] pain in throat [oropharyngeal pain] cannot talk because of surgery, entire digestive tract affected/can eat more solid things, before just ate liquid [gastrointestinal disorder] doctor removed mucous [mucosal disorder] hard to talk.Speaks slowly [speech disorder] case description: a spontaneous report was received via email on 15-jun-2021 from a consumer, unknown gender, age: over 60 years, who used interdental oral-b manual dental floss, beginning on an unspecified date, and swallowed an interdental brush head when it came apart from the handle on an unspecified date.The interdental brush head was trapped in the tonsils for 2 weeks.It was unknown if the consumer had used this version of the product previously and unknown if product use was stopped.The consumer stated that the only solution was to operate on the tonsils (surgery had not yet occurred).The event outcome of foreign body in throat was not recovered/not resolved.The case outcome was not recovered/not resolved.Relevant history: none reported.Concomitant product(s): none reported.No further information was provided.16-jun-2021 received questionnaire: the consumer, a 67 year old female, used the oral-b interdental micro-brush at least once a day, beginning in may-2021.On (b)(6) 2021, the brush she was using came apart from the handle, and the interdental brush head became embedded and stuck between two of her molars.When she tried to remove the brush head with her fingers, it was no longer lodged between the teeth because she had swallowed it.She could still feel the discomfort of the brush "jabbed" in her throat and she had the feeling of something embedded in the throat or the tonsils.She had pain that radiated towards her ear, beginning may-2021.On (b)(6) 2021, she sought medical attention with an otorhinolaryngologist.She went to the office more than five times, and had been given multiple types of exams like: scanner, x-rays, endoscopies, and introduction of microscopic elements into her throat and esophagus.She was treated with antibiotics and anti-inflammatories, however symptoms persisted.The doctors were considering a possible surgical intervention to remove the tonsils, where they assumed the brush head was encapsulated/lodged in the throat.It was the first time she had used this version of the product, and product use was stopped on (b)(6) 2021.The event outcomes were not recovered/not resolved.The case outcome remained not recovered/not resolved.Relevant history: she had no allergies.She used to use another brand that she never had problems with.No further information was provided.30-jun-2021 follow-up received via phone: the consumer reported that she still had pain in her throat, like there was something sharp in it, beginning 2021.She had been to the doctor and was diagnosed with traumatic pharyngitis, beginning 2021.The doctor told her that if her symptoms did not improve within the week, she would have to undergo surgery.The event outcomes were not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.05-jul-2021: the consumer reported that she would have to have surgery on friday to remove the object.The case outcome remained not recovered/not resolved.No further information was provided.05-jul-2021 case update received: the product was updated to oral-b manual dental floss expert interdental micro interdental no flavor-scent 10 count.The case outcome remained not recovered/not resolved.No further information was provided.12-jul-2021 follow-up received via phone: the husband reported that that his wife's entire digestive tract was affected, and she could not talk, from the surgery.The doctor told them he had removed mucous.A consultation was scheduled for (b)(6) 2021 to receive the (surgical) results.The event outcomes of foreign body in throat, sensation of foreign body, pain, pain in throat, oropharyngeal discomfort, pharyngitis, and mucosal disorder were unknown.The event outcome of digestive tract affected/cannot talk was not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.(b)(6) 2021 follow-up via phone: the husband reported that his wife still had discomfort.They did not know if the discomfort was caused by the brush or the surgical intervention.His wife was currently in consultation and they were still waiting on results.The event outcome of throat discomfort was not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.(b)(6) 2021 follow-up via phone: the husband reported that his wife was better.The wife reported that she could eat more solid things, whereas before she was just eating liquid.She had a check-up scheduled for the following week, and assumed she would get the report from the (surgical) intervention.The event outcome of foreign body in throat was unknown.The event outcomes of pharyngitis, sensation of foreign body, pain, oropharyngeal discomfort, oropharyngeal pain, gastrointestinal disorder, and mucosal disorder were improved.The case outcome was improved.No further information was provided.(b)(6) 2021 investigation results received: no manufacturing cause identified based on investigation.No further information was provided.(b)(6) 2021 follow-up via phone: an unspecified reporter stated there had been little improvement and she (the patient) had a check-up scheduled with the doctor on friday (b)(6) 2021).A lot of time had passed since the operation, and it was hard for her to talk and she spoke slowly, beginning 2021.The event outcome of hard to talk/spoke slowly was not recovered/not resolved.The case outcome remained improved.No further information was provided.
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Manufacturer Narrative
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(b)(6) 2021, product investigation results: product return was received at reported region.Product investigation results showed that complaint was caused by a breakage of interdental handle due to improper consumer handling.
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Manufacturer Narrative
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24-aug-2021, product investigation results: product return was received at reported region.Product investigation results showed that complaint was caused by a breakage of interdental handle due to improper consumer handling.
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Event Description
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Interdental brush head encapsulated.Trapped in tonsils, some part of throat [foreign body in throat] interdental brush head came apart from handle and stuck between two molars [device breakage] swallowed interdental brush head [exposure via ingestion] interdental brush came apart during use.Swallowed brush head [accidental device ingestion] traumatic pharyngitis [pharyngitis] could feel brush "jabbed" in throat/had feeling of something embedded in throat, tonsils [sensation of foreign body] radiating pain toward ipsilateral ear [pain] discomfort of feeling something jabbed in throat/pharyngeal discomfort lateralized to right, predominantly nocturnal (radiating to right ear) [oropharyngeal discomfort] pain in throat/pain lower right pharynx region [oropharyngeal pain] cannot talk because of surgery, entire digestive tract affected/can eat more solid things, before just ate liquid [gastrointestinal disorder] doctor removed mucous [mucosal disorder] hard to talk.Speaks slowly [speech disorder] larynx presented minor inflammation of the posterior and subglottic commissure [laryngeal inflammation] partial occlusion of the right vallecula of unspecific aspect [pharyngeal disorder] case description: a spontaneous report was received via email on (b)(6) 2021 from a consumer, unknown gender, age: over 60 years, who used interdental oral-b manual dental floss, beginning on an unspecified date, and swallowed an interdental brush head when it came apart from the handle on an unspecified date.The interdental brush head was trapped in the tonsils for 2 weeks.It was unknown if the consumer had used this version of the product previously and unknown if product use was stopped.The consumer stated that the only solution was to operate on the tonsils (surgery had not yet occurred).The event outcome of foreign body in throat was not recovered/not resolved.The case outcome was not recovered/not resolved.Relevant history: none reported.Concomitant product(s): none reported.No further information was provided.(b)(6) 2021 received questionnaire: the consumer, a 67 year old female, used the oral-b interdental micro-brush at least once a day, beginning in (b)(6) 2021.On (b)(6) 2021, the brush she was using came apart from the handle, and the interdental brush head became embedded and stuck between two of her molars.When she tried to remove the brush head with her fingers, it was no longer lodged between the teeth because she had swallowed it.She could still feel the discomfort of the brush "jabbed" in her throat and she had the feeling of something embedded in the throat or the tonsils.She had pain that radiated towards her ear, beginning may-2021.On 27-may-2021, she sought medical attention with an otorhinolaryngologist.She went to the office more than five times, and had been given multiple types of exams like: scanner, x-rays, endoscopies, and introduction of microscopic elements into her throat and esophagus.She was treated with antibiotics and anti-inflammatories, however symptoms persisted.The doctors were considering a possible surgical intervention to remove the tonsils, where they assumed the brush head was encapsulated/lodged in the throat.It was the first time she had used this version of the product, and product use was stopped on 26-may-2021.The event outcomes were not recovered/not resolved.The case outcome remained not recovered/not resolved.Relevant history: she had no allergies.She used to use another brand that she never had problems with.No further information was provided.30-jun-2021 follow-up received via phone: the consumer reported that she still had pain in her throat, like there was something sharp in it, beginning 2021.She had been to the doctor and was diagnosed with traumatic pharyngitis, beginning 2021.The doctor told her that if her symptoms did not improve within the week, she would have to undergo surgery.The event outcomes were not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.05-jul-2021 follow-up received via phone: the consumer reported that she would have to have surgery on friday to remove the object.The case outcome remained not recovered/not resolved.No further information was provided.05-jul-2021 case update received: the product was updated to oral-b manual dental floss expert interdental micro interdental no flavor-scent 10 count.The case outcome remained not recovered/not resolved.No further information was provided.12-jul-2021 follow-up received via phone: the husband reported that that his wife's entire digestive tract was affected, and she could not talk, from the surgery.The doctor told them he had removed mucous.A consultation was scheduled for 19-jun-2021 to receive the (surgical) results.The event outcomes of foreign body in throat, sensation of foreign body, pain, pain in throat, oropharyngeal discomfort, pharyngitis, and mucosal disorder were unknown.The event outcome of digestive tract affected/cannot talk was not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.27-jul-2021 follow-up via phone: the husband reported that his wife still had discomfort.They did not know if the discomfort was caused by the brush or the surgical intervention.His wife was currently in consultation and they were still waiting on results.The event outcome of throat discomfort was not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.(b)(6) 2021 follow-up via phone: the husband reported that his wife was better.The wife reported that she could eat more solid things, whereas before she was just eating liquid.She had a check-up scheduled for the following week, and assumed she would get the report from the (surgical) intervention.The event outcome of foreign body in throat was unknown.The event outcomes of pharyngitis, sensation of foreign body, pain, oropharyngeal discomfort, oropharyngeal pain, gastrointestinal disorder, and mucosal disorder were improved.The case outcome was improved.No further information was provided.04-aug-2021 investigation results received: no manufacturing cause identified based on investigation.No further information was provided.09-aug-2021 follow-up via phone: an unspecified reporter stated there had been little improvement and she (the patient) had a check-up scheduled with the doctor on friday (b)(6) 2021.A lot of time had passed since the operation, and it was hard for her to talk and she spoke slowly, beginning 2021.The event outcome of hard to talk/spoke slowly was not recovered/not resolved.The case outcome remained improved.No further information was provided.23-aug-2021 received medical report: the 68 year old patient consulted the otorhinolaryngologist on 24-jun-2021 for right sided pharyngeal discomfort that had evolved over the course of the month, was predominantly nocturnal, and radiated to the right ear.The onset of the discomfort had occurred after she had accidentally swallowed a fragment of an interdental hygiene device, and had not been relieved after prolonged treatment with esomeprazole.The physical exam of the ears, nose and throat was normal.There was no dysphonia or dysphagia.A nasal endoscopy was performed that day (24-jun-2021) and showed deviation of the right nasal septum, and no evidence of injuries, inflammation, or images of a foreign body in the oropharynx or hypopharynx.The larynx presented minor inflammation of the posterior and subglottic commissure, and the vocal cords were healthy.The patient had already undergone previous exams and imaging for her symptoms.On (b)(6) 2021, an upper digestive endoscopy was performed that showed a small sliding hiatal hernia, no associated esophagitis, and no foreign body.On (b)(6) 2021, a neck computerised tomogram showed partial occlusion of the right vallecula (unspecified aspect) with no evidence of underlying injury, small hypodense bilateral thyroid nodules, and no evidence of foreign body in the airway or upper digestive.On (b)(6) 2021, a lateral x-ray of the neck did not show images suggestive of radio-opaque foreign body in the projections, and the fluoroscopy that evaluated the soft parts showed no alterations.Due to the patient's persistent symptoms, and that all test results were negative thus far, it was decided that an endoscopic exploration would be performed in the operating room.On 09-jul-2021, under general anesthesia, a direct laryngoscopy and endoscopy was performed of the oropharynx and hypopharynx, including the base of the tongue, vallecula, and pyriform sinus.There were no findings of injuries or evidence of pharyngeal foreign body, and there were no alterations found when the base of the tongue and right tonsil were probed.Due to the lack of findings from the endoscopy, and possibility that there could be a foreign body inside the tonsil, a right intracapsular tonsillectomy with radiofrequency (coblation device) was performed.The majority of the right tonsil tissue was vaporized and there was no evidence of foreign body.A postoperative check-up on 13-aug-2021 showed the remaining right tonsil was healed.The patient continued to have sharp, persistent pain in the lower right pharynx region, and radiating pain toward the ipsilateral ear.The event outcomes of laryngeal inflammation and partial occlusion of the right vallecula were unknown.The case outcome remained improved.Relevant history: hashimoto's thyroiditis and sulfa allergy.No further information was provided.23-aug-2021 follow-up via phone: an unspecified reporter stated that she (the patient) was much better and about 50 percent recovered.The event outcome of hard to talk/spoke slowly was improved.The case outcome remained improved.No further information was provided.
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Event Description
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Interdental brush head encapsulated.Trapped in tonsils, some part of throat [foreign body in throat].Interdental brush head came apart from handle and stuck between two molars [device breakage].Swallowed interdental brush head [exposure via ingestion].Interdental brush came apart during use.Swallowed brush head [accidental device ingestion].Traumatic pharyngitis [pharyngitis].Could feel brush "jabbed" in throat/had feeling of something embedded in throat, tonsils [sensation of foreign body].Pain radiates towards ear [pain].Discomfort of feeling something jabbed in throat/discomfort - throat [oropharyngeal discomfort].Pain in throat [oropharyngeal pain].Cannot talk because of surgery, entire digestive tract affected/can eat more solid things, before just ate liquid [gastrointestinal disorder].Doctor removed mucous [mucosal disorder].Case description: a spontaneous report was received via email on 15-jun-2021 from a consumer, unknown gender, age: over 60 years, who used interdental oral-b manual dental floss, beginning on an unspecified date, and swallowed an interdental brush head when it came apart from the handle on an unspecified date.The interdental brush head was trapped in the tonsils for 2 weeks.It was unknown if the consumer had used this version of the product previously and unknown if product use was stopped.The consumer stated that the only solution was to operate on the tonsils (surgery had not yet occurred).The event outcome of foreign body in throat was not recovered/not resolved.The case outcome was not recovered/not resolved.Relevant history: none reported.Concomitant product(s): none reported.No further information was provided.16-jun-2021 received questionnaire: the consumer, a 67 year old female, used the oral-b interdental micro-brush at least once a day, beginning in (b)(6) 2021.On (b)(6) 2021, the brush she was using came apart from the handle, and the interdental brush head became embedded and stuck between two of her molars.When she tried to remove the brush head with her fingers, it was no longer lodged between the teeth because she had swallowed it.She could still feel the discomfort of the brush "jabbed" in her throat and she had the feeling of something embedded in the throat or the tonsils.She had pain that radiated towards her ear, beginning (b)(6) 2021.On (b)(6) 2021, she sought medical attention with an otorhinolaryngologist.She went to the office more than five times, and had been given multiple types of exams like: scanner, x-rays, endoscopies, and introduction of microscopic elements into her throat and esophagus.She was treated with antibiotics and anti-inflammatories, however symptoms persisted.The doctors were considering a possible surgical intervention to remove the tonsils, where they assumed the brush head was encapsulated/lodged in the throat.It was the first time she had used this version of the product, and product use was stopped on (b)(6) 2021.The event outcomes were not recovered/not resolved.The case outcome remained not recovered/not resolved.Relevant history: she had no allergies.She used to use another brand that she never had problems with.No further information was provided.30-jun-2021 follow-up received via phone: the consumer reported that she still had pain in her throat, like there was something sharp in it, beginning 2021.She had been to the doctor and was diagnosed with traumatic pharyngitis, beginning 2021.The doctor told her that if her symptoms did not improve within the week, she would have to undergo surgery.The event outcomes were not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.05-jul-2021 follow-up received via phone: the consumer reported that she would have to have surgery on friday to remove the object.The case outcome remained not recovered/not resolved.No further information was provided.05-jul-2021 case update received: the product was updated to oral-b manual dental floss expert interdental micro interdental no flavor-scent 10 count.The case outcome remained not recovered/not resolved.No further information was provided.12-jul-2021 follow-up received via phone: the husband reported that his wife's entire digestive tract was affected, and she could not talk, from the surgery.The doctor told them he had removed mucous.A consultation was scheduled for (b)(6) 2021 to receive the (surgical) results.The event outcomes of foreign body in throat, sensation of foreign body, pain, pain in throat, oropharyngeal discomfort, pharyngitis, and mucosal disorder were unknown.The event outcome of digestive tract affected/cannot talk was not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.27-jul-2021 follow-up via phone: the husband reported that his wife still had discomfort.They did not know if the discomfort was caused by the brush or the surgical intervention.His wife was currently in consultation and they were still waiting on results.The event outcome of throat discomfort was not recovered/not resolved.The case outcome remained not recovered/not resolved.No further information was provided.02-aug-2021 follow-up via phone: the husband reported that his wife was better.The wife reported that she could eat more solid things, whereas before she was just eating liquid.She had a check-up scheduled for the following week, and assumed she would get the report from the (surgical) intervention.The event outcome of foreign body in throat was unknown.The event outcomes of pharyngitis, sensation of foreign body, pain, oropharyngeal discomfort, oropharyngeal pain, gastrointestinal disorder, and mucosal disorder were improved.The case outcome was improved.No further information was provided.04-aug-2021 investigation results received: no manufacturing cause identified based on investigation.No further information was provided.
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Manufacturer Narrative
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11-aug-2021: product investigation results: product return was received at reported region.Product investigation results showed that complaint was caused by a breakage of interdental handle due to improper consumer handling.
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Search Alerts/Recalls
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