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| Device Problem
Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Unspecified Infection (1930); Scarring (2061); Burn, Thermal (2530)
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| Event Date 01/01/2017 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] experienced a burn with a quarter size blister on her stomach [burns second degree] , sleeping while wearing the heatwrap (usually uses it at night), read usage instructions prior to use [intentional device misuse] , she had a quarter size blister on her stomach.It got infected [blister infected], there is a scar there now.[scar].Case narrative: this is a spontaneous report from a contactable consumer, reporting on behalf of their daughter.This (b)(6) female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number and expiration date were unknown) from an unspecified date in late 2017 for less than 8 hours applied as needed to the lower abdomen for menstrual cramps.Medical history included ongoing ear issues (taking medication), ongoing rapid heart rate (taking medication) and ongoing thyroid disorder (taking medication) all from unspecified dates.The patient was not pregnant.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in 2017 for an unspecified indication with no adverse effect (reported as great results).Concomitant medications included unspecified medications for ear disorder, rapid heart rate and thyroid disorder.The reporter stated her daughter experienced a burn with a quarter size blister on her stomach from the menstrual wrap at the end of last year (2017).The patient was sleeping while wearing the heatwrap (usually uses it at night) and the heatwraps was applied to her underwear per instructions.It was reported the blister got infected and there is a scar there now.The blister took a couple weeks to heal.The patient did not consult a healthcare professional as a result of the events.The reporter was concerned the heatwrap could have been one of the recalled thermacare products.The patient's skin tone was classified as very light.The patient denied having sensitive skin or any abnormal skin conditions.The menstrual wraps came from a red box.The patient used the heatwraps as needed, maybe 1 to 2 days for less than 8 hours each use.The patient previously used a heating pad and sometimes a microwave gel pack on unknown dates with no problems or symptoms experienced.She was currently under the care of a physician for ear issues, rapid heart rate and thyroid.The patient did not engage in exercise while wearing the heatwrap.She stated she did check her skin under the product while using the heatwrap.The patient had read the usage instructions prior to using the heatwraps.She denied taking any mediations (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.The product had been discarded by the patient.Action taken with the suspect product was permanently withdrawn in early 2018.Therapeutic measures taken included treatment at home of neosporin along with soap and water and gauze pads with tape.Clinical outcome of the events burn blister and blister infection was resolved with sequelae in early 2018.Clinical outcome of the event scar was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of 'burns second degree, intentional device misuse and blister infected' as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event scar was medical assessed as non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of 'burns second degree, intentional device misuse and blister infected' as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event scar was medical assessed as non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] experienced a burn with a quarter size blister on her stomach/blister/burn/burns big blisters that got infected [burns second degree] , sleeping while wearing the heatwrap (usually uses it at night), read usage instructions prior to use [intentional device misuse] , she had a quarter size blister on her stomach.It got infected [blister infected] , there is a scar there now.[scar] ,.Case narrative:this is a spontaneous report from a contactable consumer, reporting on behalf of their daughter and a contactable consumer (patient).This 35-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number and expiration date were unknown) from an unspecified date in late 2017 ''dec to dec' for less than 8 hours applied as needed to the lower abdomen for menstrual cramps.Medical history included ongoing ear issues (taking medication), ongoing rapid heart rate (taking medication) and ongoing thyroid disorder (taking medication) all from unspecified dates.The patient was not pregnant and is not post menopausal.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in 2000 'for 3 years' (previously reported from an unspecified date in 2017) for an unspecified indication with no adverse effect (reported as great results) previously experienced no problems or symptoms with any of these products.Concomitant medications included unspecified medications for ear disorder, rapid heart rate and thyroid disorder.The reporter stated her daughter experienced a burn with a quarter size blister on her stomach from the menstrual wrap at the end of last year (2017).Patient stated 'i got burns big blisters that got infected on 06dec2017 that lasted a month or so.The patient was sleeping while wearing the heatwrap (usually uses it at night), for 2 hrs or more but on the day she experienced the event she used the product for 1 hour, had used the product 7 days in a row and the heatwraps was applied to her underwear per instructions.It was reported the blister got infected.There is a scar there now in dec2017 no treatment provided.The blister took a couple weeks to heal.The patient did not consult a healthcare professional as a result of the events.No hospitalization was involved.The reporter was concerned the heatwrap could have been one of the recalled thermacare products.The patient's skin tone was classified as very light or fair and she does have sensitive skin.The patient denied any abnormal skin conditions.The menstrual wraps came from a red box.The patient initially reported she used the heatwraps as needed, maybe 1 to 2 days for less than 8 hours each use.The patient previously used a heating pad and sometimes a microwave gel pack october (year not provided) 'for 4 years' with no problems or symptoms experienced.She was currently under the care of a physician for ear issues, rapid heart rate and thyroid.The patient did not engage in exercise while wearing the heatwrap.She stated she did check her skin under the product while using the heatwrap.The patient had read the usage instructions prior to using the heatwraps.She denied taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.The product had been discarded by the patient.Action taken with the suspect product was permanently withdrawn in early 2018.Therapeutic measures taken included treatment at home of neosporin along with soap and water and gauze pads with tape.Clinical outcome of the events burn and blister infection was resolved in early 2018 and scar was resolved on an unspecified date.Follow-up attempts are completed.No further information is expected follow-up (26dec2018): additional information received from a contactable consumer(patient) included: product data, event details, no hospitalization, no treatment.Event onset and outcome follow-up attempts are completed.No further information is expected.Company clinical evaluation comment based on the information provided, the events of 'burns second degree, intentional device misuse and blister infected' as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event scar was medical assessed as non-serious.The events are medically assessed as associated with the use of the device, comment: based on the information provided, the events of 'burns second degree, intentional device misuse and blister infected' as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event scar was medical assessed as non-serious.The events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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There was no reasonable suggestion of device malfunction.The status of the sample at the site was not received.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: (b)(6) 2015 through (b)(6) 2018 / manufacturing site: pfizer (site name provided) / complaint class: external cause investigation / complaint sub class: adverse event safety request for investigation: the citi customizable search returned a total of 83 complaints for menstrual 8hr products during this time period for the class/subclass : adverse event safety request for investigation.Two of the 83 were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Investigations: both of these investigations were related to investigation pr-#.Pr-# determined the most probable root cause of the event is equipment/other with method as a contributory factor.The root cause is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because a manufacturing work instruction (mwi) document for purging brine is necessary.There is not a document that clearly provides instructions on how to purge brine.Corrective actions: investigation pr-# for lots t2#, t2#, t2# & # menstrual & muscle joint us for cells damaged/leaking was conducted for the subclass of cell pack damage/leaking.These batches were reviewed at aqrt and the outcome was to recall the four batches (t2#, t2#, and t2# & #).Recall issued in (b)(6) 2018.Preventive actions (pa): pa 1 pr#: create an mwi for purging brine.Thi.
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Event Description
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Event verbatim [preferred term] experienced a burn with a quarter size blister on her stomach/blister/burn/burns big blisters that got infected [burns second degree] , sleeping while wearing the heatwrap (usually uses it at night), read usage instructions prior to use [intentional device misuse] , she had a quarter size blister on her stomach.It got infected [blister infected] , there is a scar there now.[scar].Case narrative:this is a spontaneous report from a contactable consumer, reporting on behalf of their daughter and a contactable consumer (patient).This 35-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number and expiration date were unknown) from an unspecified date in late 2017 ''dec to dec" for less than 8 hours applied as needed to the lower abdomen for menstrual cramps.Medical history included ongoing ear issues (taking medication), ongoing rapid heart rate (taking medication) and ongoing thyroid disorder (taking medication) all from unspecified dates.The patient was not pregnant and is not post menopausal.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in 2000 "for 3 years" (previously reported from an unspecified date in 2017) for an unspecified indication with no adverse effect (reported as great results) previously experienced no problems or symptoms with any of these products.Concomitant medications included unspecified medications for ear disorder, rapid heart rate and thyroid disorder.The reporter stated her daughter experienced a burn with a quarter size blister on her stomach from the menstrual wrap at the end of last year (2017).Patient stated "i got burns big blisters that got infected on (b)(6) 2017 that lasted a month or so." the patient was sleeping while wearing the heatwrap (usually uses it at night), for 2 hrs or more but on the day she experienced the event she used the product for 1 hour, had used the product 7 days in a row and the heatwraps was applied to her underwear per instructions.It was reported the blister got infected.There is a scar there now in (b)(6) 2017 no treatment provided.The blister took a couple weeks to heal.The patient did not consult a healthcare professional as a result of the events.No hospitalization was involved.The reporter was concerned the heatwrap could have been one of the recalled thermacare products.The patient's skin tone was classified as very light or fair and she does have sensitive skin.The patient denied any abnormal skin conditions.The menstrual wraps came from a red box.The patient initially reported she used the heatwraps as needed, maybe 1 to 2 days for less than 8 hours each use.The patient previously used a heating pad and sometimes a microwave gel pack october (year not provided) "for 4 years" with no problems or symptoms experienced.She was currently under the care of a physician for ear issues, rapid heart rate and thyroid.The patient did not engage in exercise while wearing the heatwrap.She stated she did check her skin under the product while using the heatwrap.The patient had read the usage instructions prior to using the heatwraps.She denied taking any medications (including over-the-counter, herbal, nutritional or any applied to the skin) during the time the problem/symptom was experienced.The product had been discarded by the patient.Action taken with the suspect product was permanently withdrawn in early 2018.Therapeutic measures taken included treatment at home of neosporin along with soap and water and gauze pads with tape.Clinical outcome of the events burn and blister infection was resolved in early 2018 and scar was resolved on an unspecified date.Product quality complaints provided the following investigation information: there was no reasonable suggestion of device malfunction.The status of the sample at the site was not received.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: (b)(6) 2015 through (b)(6) 2018 / manufacturing site: pfizer (site name provided) / complaint class: external cause investigation / complaint sub class: adverse event safety request for investigation: the citi customizable search returned a total of 83 complaints for menstrual 8hr products during this time period for the class/subclass : adverse event safety request for investigation.Two of the 83 were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Investigations: both of these investigations were related to investigation pr-#.Pr-# determined the most probable root cause of the event is equipment/other with method as a contributory factor.The root cause is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because a manufacturing work instruction (mwi) document for purging brine is necessary.There is not a document that clearly provides instructions on how to purge brine.Corrective actions: investigation pr-# for lots t2#, t2#, t2# & # menstrual & muscle joint us for cells damaged/leaking was conducted for the subclass of cell pack damage/leaking.These batches were reviewed at aqrt and the outcome was to recall the four batches (t2#, t2#, and t2# & #).Recall issued in (b)(6) 2018.Preventive actions (pa): pa 1 pr#: create an mwi for purging brine.This document needs to provide instructions on how to verify air isn't within the supply lines and it should provide instruction on how to ensure the lines are secure to the connectors to prevent any air from entering the system.Also, the document should provide instructions on how long to purge based off of the downtime, see pr#.Completed: (b)(6) 2019.Pa 2: replace current brine manifold to dispensing plate supply lines (push/pull quick disconnect) with a line with a permanent (screw on) connector design, see pr#.Completed: (b)(6) 2019.Pa 3: implement hpm hourly inspection.This inspection should include: inspecting for proper brine dispensing, stray chemistry, build-up in platens & seal roll cleanliness, see pr#.Completed: (b)(6) 2019.Pa 4: complete evaluation of the wrap size and determine the need to increase the outside border of the wrap from 3 mm to 5 mm, see pr#.Completed: (b)(6) 2018.Pa 5: complete evaluation of brine solution detectability by the quality check camera's either by coloring the brine solution or use of a strong uv absorber, see pr#.Completed: (b)(6) 2018.Pa 6: update failure mode effective analysis rpt-39239 to reflect above stated mitigation actions for "brine outside cell." pr#.Completed: (b)(6) 2018.Pa 7: identify all previous complaint investigations due to unsealed cells for the 4 batches included in the scope of this investigation.Update to make current and correct any errors within the complaint investigations, see pr-#.Completed: (b)(6) 2018.There was an increase in complaints for the months of (b)(6) 2018; as a result of the menstrual recall issued in (b)(6) 2018.The increase in complaints for the month of (b)(6) 2017 were related to burns and blisters.This was due to a seasonality change.Based on this citi customizable search for the subclasses of adverse event safety request for investigation for menstrual 8hr products the data did not show an increase over time for 36-months.There is not a trend identified for the subclass of adverse event safety request for investigation for menstrual 8hr product, (b)(6) 2015 to (b)(6) 2018.This investigation was conducted for an unknown lot number menstrual 8 hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and /or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a trend identified related for the subclass adverse event safety request for investigation.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.Follow-up attempts are completed.No further information is expected.Follow-up (26dec2018): additional information received from a contactable consumer(patient) included: product data, event details, no hospitalization, no treatment.Event onset and outcome.Follow-up attempts are completed.No further information is expected.Follow-up (25mar2020): new information received from a product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected.Comment: based on the information provided, the events of 'burns second degree, intentional device misuse and blister infected' as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event scar was medical assessed as non-serious.The events are medically assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Search Alerts/Recalls
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