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| Lot Number N31955 |
| Device Problems
Use of Device Problem (1670); Temperature Problem (3022)
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| Patient Problems
Unspecified Infection (1930); 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] burn to left hip area [thermal burn] , burn is worsening [condition aggravated] , infected bad now [burn infection] , applied heatwrap directly to skin/not able to read the instructions prior to usage as they were in (b)(6) [device use error] , it was getting too hot [device issue] , used heatwrap for cramping on left side [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n31955, expiration date: mar2019) from (b)(6) 2017 for "cramping on left side".The patient's medical history was not reported.There were no concomitant medications.On (b)(6) 2017, the patient was on vacation in (b)(6) and applied the heatwrap directly to her skin between her left hip and pelvic area and went sightseeing for an unknown number of hours.She stated she kept shifting the wrap around if she felt it was getting too hot.The patient reported she was moving the heatwrap and her finger touched burn area.She stated she did not feel anything "like oh my god i'm burning!", her thumb hit the burn when moving it and that was how she knew she was burned.Burn to left hip area was reported as worsened.The heatwrap had burned her skin pretty badly between her left hip and pelvic area.It wasn't as horrific at first as it is now.It was just a regular burn when she spoke to the pharmacist.She stated it is now getting infected.The patient mentioned the product was purchased in (b)(6) while on vacation and the burn occurred when in (b)(6) as well.She stated she not been to an md regarding this burn as she was on vacation, but may go.While in (b)(6) , the patient did consult a pharmacist that recommended a burn cream called biafine trolamine.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.Therapeutic measures taken included burn cream biafine trolamine.The patient assessed her skin tone as fair.The patient is not currently under the care of a physician for any medical conditions.She denied having sensitive skin or any abnormal skin conditions.The patient had not previously used thermacare heatwraps.She had previously used a heating pad with no problems experienced.The patient was wearing underwear and pants over the wrap as well as a shirt and jacket (reported as "nothing heavy or bulky").She did not engage in exercise while using the heatwrap.She checked her skin frequently during use.The patient was not able to read the instructions prior to usage as they were in (b)(6).She stated she looked at the pictures on the box and did what it said.The patient used the wrap over healthy skin and over the correct part of the body.She did not overlap the wrap and did not apply any pressure over the wrap.The patient has discarded the wrap she was wearing when the burn occurred.There was no damage to the packaging and the heatwraps were sealed appropriately.Clinical outcome of the event burn was not resolved.Clinical outcome of the remaining events was unknown.The event occurred in a country different from that of the reporter.This may be a duplicate if the reporter also submitted directly to his/her local agency.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 "burn/ got worsening" "burn infection" "used the wrap over healthy skin/not able to read the instructions prior to usage" "felt it was getting too hot" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burn/ got worsening" "burn infection" "used the wrap over healthy skin/not able to read the instructions prior to usage" "felt it was getting too hot" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Visual inspection of a retain sample included one carton and the two pouched wraps inside shows no obvious defects.Review of the batch device history record for this batch concludes all release requirements were met.The review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the two day run report a total of 26 wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature in process limits.A total of 624 pti (pouch leak) tests were performed with no failures.The shift production record was reviewed, there were no mention of incidents during manufacturing that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.After a review of the batch thermal records, thermal results all met product release criteria.The product effect may vary with each individual.Final confirmation status was reported as not confirmed.
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Event Description
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Event verbatim [preferred term] third degree burn on my stomach (groin area)/ burn to left hip area/burn of groin/burn of abdominal wall/pain in burned area [burns third degree], burn is worsening [condition aggravated], infected bad now [burn infection], burned a hole in my lower abdomen [wound], she will have a scar for the remainder of her life [scar], applied heatwrap directly to skin/not able to read the instructions prior to usage as they were in french [device use error], it was getting too hot/wrap got a little bit uncomfortable (not hot burning) [device issue], used heatwrap for cramping on left side/patient informed that she brought thermacare lower back for lower abdomen pain [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient with ethnicity hispanic/latino started to use thermacare heatwrap (thermacare lower back and hip) (device lot number: n31955, expiration date: mar2019, manufactured date: 18apr2016) from (b)(6) 2017 for "cramping on left side" and for pain in lower abdomen.The patient's medical history included menopause and never smoker.There were no concomitant medications.The patient lived in the usa.On (b)(6) 2017, she was on vacation in (b)(6) and applied the heatwrap directly to her skin between her left hip and pelvic area and went sightseeing for an unknown number of hours.She stated she kept shifting the wrap around if she felt it was getting too hot.The patient reported she was moving the heatwrap and her finger touched burn area.She stated she did not feel anything "like oh my god i'm burning!", her thumb hit the burn when moving it and that was how she knew she was burned.Burn to left hip area was reported as worsened in (b)(6) 2017.The heatwrap had burned her skin pretty badly between her left hip and pelvic area.It wasn't as horrific at first as it is now.It was just a regular burn when she spoke to the pharmacist.She stated it was then getting infected in (b)(6) 2017.The patient mentioned the product was purchased in france while on vacation and the burn occurred when in (b)(6) as well.She stated she had not been to an md regarding this burn as she was on vacation, but may go.While in (b)(6), the patient did consult a pharmacist that recommended a burn cream called biafine trolamine.The patient further reported that the product's instructions stated that each patch can be worn for a 16-hour time frame.However, after approximately 4 to 5 hours, she noticed a severe burning sensation in the section of her abdomen/burn of abdominal wall where she had applied the patch.She removed the patch and was horrified to find out that the patch had burned a hole in my lower abdomen on (b)(6) 2017.As a result of the pain associated with the burn caused by your product, her vacation was ruined.Since returning home she had to consult with a physician four times regarding the injury caused by the product.She had been diagnosed as suffering a third degree burn on her stomach (groin area)/ burn of groin and she will have a scar (2017) for the remainder of her life.Patient with small 3rd burn left lower abdomen due to heating injury in insensate skin of abdominoplasty flap.Wound was healing well with silvadene dressing.Other treatment includes: silver sulfadiazine (silvadene/thermazene) 1 % top cream, cephalexin (keflex) 500 mg oral cap."i am writing directly to you in order to inform you of your products defectiveness and also to obtain compensation for the pain, suffering, life time soar, and medical expenses that i have and will incur in connection with this injury.I was advised by my doctor to write to you directly, prior to obtaining legal counsel.However, time is of the essence in resolving this matter.As such, unless you reply to my request within thirty days from the date of this letter, i will retain counsel to represent me in this matter." she had lab data on an unspecified date included blood pressure: 136/78 mmhg; pulse: 72; temperature (src): 98 degree f (36.7 degree c) (tympanic); respiratory rate: 16; weight (wt): (b)(6), body mass index: (b)(6); body surface area: 1.70 m2.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.The patient assessed her skin tone as fair.The patient is not currently under the care of a physician for any medical conditions.She denied having sensitive skin or any abnormal skin conditions.The patient had not previously used thermacare heatwraps.She had previously used a heating pad with no problems experienced.The patient was wearing underwear and pants over the wrap as well as a shirt and jacket (reported as "nothing heavy or bulky").She did not engage in exercise while using the heatwrap.She checked her skin frequently during use.The patient was not able to read the instructions prior to usage as they were in french.She stated she looked at the pictures on the box and did what it said.The patient used the wrap over healthy skin and over the correct part of the body.She did not overlap the wrap and did not apply any pressure over the wrap.The patient has discarded the wrap she was wearing when the burn occurred.There was no damage to the packaging and the heatwraps were sealed appropriately.Clinical outcome of the events third degree burns, burn is worsening, infected bad now, burned a hole in my lower abdomen was resolving.Clinical outcome of the other events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Visual inspection of a retain sample included one carton and the two pouched wraps inside shows no obvious defects.Review of the batch device history record for this batch concludes all release requirements were met.The review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the two day run report a total of 26 wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature in process limits.A total of 624 pti (pouch leak) tests were performed with no failures.The shift production record was reviewed, there were no mention of incidents during manufacturing that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.After a review of the batch thermal records, thermal results all met product release criteria.The product effect may vary with each individual.Final confirmation status was reported as not confirmed.Additional information has been requested and will be provided as it becomes available.Follow-up (23jun2017, 26jun2017 and 27jun2017): new information received from a contactable consumer includes: ethnicity, indication, medical history, lab data, more events treatment information.Added new events "burned a hole in my lower abdomen", "she would have a scar for the remainder of her life".Updated event term "burn to left hip area" to "third degree burn on my stomach (groin area)/ burn to left hip area/burn of groin/burn of abdominal wall/pain in burned area", and coded from "thermal burn" to "burns third degree".Follow-up (29jun2017): new information received from product quality complaints (pqc) group included: product quality investigation results.All events occurred in a country different from that of the reporter.This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
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Event Description
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Event verbatim [preferred term] third degree burn on my stomach (groin area)/ burn to left hip area/burn of groin/burn of abdominal wall/pain in burned area [burns third degree], burn is worsening [condition aggravated], infected bad now [burn infection], burned a hole in my lower abdomen [wound], she will have a scar for the remainder of her life [scar], applied heatwrap directly to skin/not able to read the instructions prior to usage as they were in french [device use error], it was getting too hot [device issue], used heatwrap for cramping on left side/patient informed that she brought thermacare lower back for lower abdomen pain [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient with ethnicity hispanic/latino started to use thermacare heatwrap (thermacare lower back and hip) (device lot number: n31955, expiration date: mar2019) from (b)(6) 2017 for "cramping on left side" and for pain in lower abdomen.The patient's medical history included menopause and never smoker.There were no concomitant medications.The patient lived in the usa.On (b)(6) 2017, she was on vacation in (b)(6) and applied the heatwrap directly to her skin between her left hip and pelvic area and went sightseeing for an unknown number of hours.She stated she kept shifting the wrap around if she felt it was getting too hot.The patient reported she was moving the heatwrap and her finger touched burn area.She stated she did not feel anything "like oh my god i'm burning!", her thumb hit the burn when moving it and that was how she knew she was burned.Burn to left hip area was reported as worsened in (b)(6) 2017.The heatwrap had burned her skin pretty badly between her left hip and pelvic area.It wasn't as horrific at first as it is now.It was just a regular burn when she spoke to the pharmacist.She stated it was then getting infected in (b)(6) 2017.The patient mentioned the product was purchased in france while on vacation and the burn occurred when in (b)(6) as well.She stated she had not been to an md regarding this burn as she was on vacation, but may go.While in (b)(6), the patient did consult a pharmacist that recommended a burn cream called biafine trolamine.The patient further reported that the product's instructions stated that each patch can be worn for a 16-hour time frame.However, after approximately 4 to 5 hours, she noticed a severe burning sensation in the section of her abdomen/burn of abdominal wall where she had applied the patch.She removed the patch and was horrified to find out that the patch had burned a hole in my lower abdomen on (b)(6) 2017.As a result of the pain associated with the burn caused by your product, her vacation was ruined.Since returning home she had to consult with a physician four times regarding the injury caused by the product.She had been diagnosed as suffering a third degree burn on her stomach (groin area)/ burn of groin and she will have a scar (2017) for the remainder of her life.Patient with small 3rd burn left lower abdomen due to heating injury in insensate skin of abdominoplasty flap.Wound was healing well with silvadene dressing.Other treatment includes: silver sulfadiazine (silvadene/thermazene) 1 % top cream, cephalexin (keflex) 500 mg oral cap."i am writing directly to you in order to inform you of your products defectiveness and also to obtain compensation for the pain, suffering, life time soar, and medical expenses that i have and will incur in connection with this injury.I was advised by my doctor to write to you directly, prior to obtaining legal counsel.However, time is of the essence in resolving this matter.As such, unless you reply to my request within thirty days from the date of this letter, i will retain counsel to represent me in this matter." she had lab data on an unspecified date included blood pressure: 136/78 mmhg; pulse: 72; temperature (src): 98 degree f (36.7 degree c) (tympanic); respiratory rate: 16; weight (wt): (b)(6), body mass index: (b)(6); body surface area: 1.70 m2.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.The patient assessed her skin tone as fair.The patient is not currently under the care of a physician for any medical conditions.She denied having sensitive skin or any abnormal skin conditions.The patient had not previously used thermacare heatwraps.She had previously used a heating pad with no problems experienced.The patient was wearing underwear and pants over the wrap as well as a shirt and jacket (reported as "nothing heavy or bulky").She did not engage in exercise while using the heatwrap.She checked her skin frequently during use.The patient was not able to read the instructions prior to usage as they were in french.She stated she looked at the pictures on the box and did what it said.The patient used the wrap over healthy skin and over the correct part of the body.She did not overlap the wrap and did not apply any pressure over the wrap.The patient has discarded the wrap she was wearing when the burn occurred.There was no damage to the packaging and the heatwraps were sealed appropriately.Clinical outcome of the events third degree burns, burn is worsening, infected bad now, burned a hole in my lower abdomen was resolving.Clinical outcome of the other events was unknown.All events occurred in a country different from that of the reporter.This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.Additional information has been requested and will be provided as it becomes available.Follow-up (23jun2017, 26jun2017 and 27jun2017): new information received from a contactable consumer includes: ethnicity, indication, medical history, lab data, more events treatment information.Added new events "burned a hole in my lower abdomen", "she would have a scar for the remainder of her life".Updated event term "burn to left hip area" to "third degree burn on my stomach (groin area)/ burn to left hip area/burn of groin/burn of abdominal wall/pain in burned area", and coded from "thermal burn" to "burns third degree".Company clinical evaluation comment: based on the information provided, the events of third degree burn, burn worsening, burn infection, wound, scar, device use error and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The serious events and the non serious event of device use issue are medically assessed as associated with the use of the device., comment: based on the information provided, the events of third degree burn, burn worsening, burn infection, wound, scar, device use error and device issue as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The serious events and the non serious event of device use issue are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Visual inspection of a retain sample included one carton and the two pouched wraps inside shows no obvious defects.Review of the batch device history record for this batch concludes all release requirements were met.The review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the two day run report a total of 26 wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature in process limits.A total of 624 pti (pouch leak) tests were performed with no failures.The shift production record was reviewed, there were no mention of incidents during manufacturing that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.After a review of the batch thermal records, thermal results all met product release criteria.The product effect may vary with each individual.Final confirmation status was reported as not confirmed.
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Event Description
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Third degree burn on my stomach (groin area)/ burn to left hip area/burn of groin/burn of abdominal wall/pain in burned area [burns third degree] , burn is worsening [condition aggravated] , infected bad now [burn infection] , burned a hole in my lower abdomen [wound] , she will have a scar for the remainder of her life [scar] , applied heatwrap directly to skin/not able to read the instructions prior to usage as they were in (b)(6) [device use error] , it was getting too hot/wrap got a little bit uncomfortable (not hot burning) [device issue] , used heatwrap for cramping on left side/patient informed that she bought thermacare lower back for lower abdomen pain [device use issue] ,.Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) female patient with (b)(6) started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n31955, expiration date: mar2019, manufactured date: 18apr2016) from (b)(6) 2017 for "cramping on left side" and for pain in lower abdomen.The patient's medical history included menopause and never smoker.There were no concomitant medications.The patient lived in the usa.On (b)(6) 2017, she was on vacation in (b)(6) and applied the heatwrap directly to her skin between her left hip and pelvic area and went sightseeing for an unknown number of hours.She stated she kept shifting the wrap around if she felt it was getting too hot.The patient reported she was moving the heatwrap and her finger touched a burn area.She stated she did not feel anything "like oh my god i'm burning!", her thumb hit the burn when moving the heatwrap and that was how she knew she was burned.Burn to left hip area was reported as worsened on an unspecified date in (b)(6) 2017.The heatwrap had burned her skin pretty badly between her left hip and pelvic area.It wasn't as horrific at first as it is now.It was just a regular burn when she spoke to the pharmacist.She stated it was then getting infected on an unspecified date in (b)(6) 2017.The patient mentioned the product was purchased in (b)(6) while on vacation and the burn occurred when in (b)(6) as well.She stated she had not been to an md regarding this burn as she was on vacation, but may go.While in (b)(6), the patient did consult a pharmacist that recommended a burn cream called biafine trolamine.The patient further reported that the product's instructions stated that each patch can be worn for a 16-hour time frame.However, after approximately 4 to 5 hours, she noticed a severe burning sensation in the section of her abdomen/burn of abdominal wall where she had applied the patch.She removed the patch and was horrified to find out that the patch had burned a hole in her lower abdomen on (b)(6) 2017.As a result of the pain associated with the burn caused by your product, her vacation was ruined.Since returning home she had to consult with a physician four times regarding the injury caused by the product.She had been diagnosed as suffering a third degree burn on her stomach (groin area)/ burn of groin and she will have a scar (2017) for the remainder of her life.Patient with small 3rd burn left lower abdomen due to heating injury in insensate skin of abdominoplasty flap.Wound was healing well with silvadene dressing.Other treatment includes: silver sulfadiazine (silvadene/thermazene) 1 % topical cream, cephalexin (keflex) 500 mg oral capsules.The patient stated "i am writing directly to you in order to inform you of your products defectiveness and also to obtain compensation for the pain, suffering, life time sore, and medical expenses that i have and will incur in connection with this injury.I was advised by my doctor to write to you directly, prior to obtaining legal counsel.However, time is of the essence in resolving this matter.As such, unless you reply to my request within thirty days from the date of this letter, i will retain counsel to represent me in this matter." she had lab data on an unspecified date which included blood pressure: 136/78 mmhg; pulse: 72; temperature (src): 98 degree f (36.7 degree c) (tympanic); respiratory rate: 16; weight (wt): (b)(6).Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.The patient assessed her skin tone as fair.The patient is not currently under the care of a physician for any medical conditions.She denied having sensitive skin or any abnormal skin conditions.The patient had not previously used thermacare heatwraps.She had previously used a heating pad with no problems experienced.The patient was wearing underwear and pants over the wrap as well as a shirt and jacket (reported as "nothing heavy or bulky").She did not engage in exercise while using the heatwrap.She checked her skin frequently during use.The patient was not able to read the instructions prior to usage as they were in (b)(6).She stated she looked at the pictures on the box and did what it said.The patient used the wrap over healthy skin and over the correct part of the body.She did not overlap the wrap and did not apply any pressure over the wrap.The patient has discarded the wrap she was wearing when the burn occurred.There was no damage to the packaging and the heatwraps were sealed appropriately.Clinical outcome of the events third degree burns, burn is worsening, infected bad now, burned a hole in my lower abdomen was resolving.Clinical outcome of the other events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Visual inspection of a retain sample included one carton and the two pouched wraps inside shows no obvious defects.Review of the batch device history record for this batch concludes all release requirements were met.The review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the two day run report a total of 26 wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature in process limits.A total of 624 pti (pouch leak) tests were performed with no failures.The shift production record was reviewed, there were no mention of incidents during manufacturing that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.After a review of the batch thermal records, thermal results all met product release criteria.The product effect may vary with each individual.Final confirmation status was reported as not confirmed.Additional information has been requested and will be provided as it becomes available.Follow-up (23jun2017, 26jun2017 and 27jun2017): new information received from a contactable consumer includes: ethnicity, indication, medical history, lab data, more events treatment information.Added new events "burned a hole in my lower abdomen", "she would have a scar for the remainder of her life".Updated event term "burn to left hip area" to "third degree burn on my stomach (groin area)/ burn to left hip area/burn of groin/burn of abdominal wall/pain in burned area", and coded from "thermal burn" to "burns third degree".Follow-up (29jun2017): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (18aug2017): new information received from a contactable consumer includes: this female patient wore thermacare heatwrap (thermacare lower back and hip) approximately for 4 to 5 hours for cramps on (b)(6) 2017.She had previously used unknown heating products for pain relief on (b)(6) 2017 for 20 min with no problems experienced.She checked her skin every time it got too warm, she felt a very hot burn and when she looked at her skin it was already peeling off and little black granules/sand like things were on the burn on her skin.It was reported that only one little pouch broke and burned her skin.Alternatively it was reported that, she had third degree burn until approximately the week of (b)(6) 2017.It was also reported that her pain was gone and only a very ugly scar remained.On (b)(6) 2017, her physician examined her burn.She was treated with sulfadiazine silver (thermazene) and sulfadiazine silver (silvadene) since (b)(6) 2017 for the reported events.She also treated with cefalexin (keflex) antibiotic from (b)(6) 2017 to an unknown date for infection.As of (b)(6) 2017, the clinical outcome of the events she will have a scar for the remainder of her life was not resolved.All events occurred in a country different from that of the reporter.This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Visual inspection of a retain sample included one carton and the two pouched wraps inside shows no obvious defects.Review of the batch device history record for this batch concludes all release requirements were met.The review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the two day run report a total of (b)(4) wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature in process limits.A total of (b)(4) pti (pouch leak) tests were performed with no failures.The shift production record was reviewed, there were no mention of incidents during manufacturing that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.After a review of the batch thermal records, thermal results all met product release criteria.The product effect may vary with each individual.Final confirmation status was reported as not confirmed.
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Event Description
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Event verbatim [preferred term] third degree burn on my stomach (groin area)/ burn to left hip area/burn of groin/burn of abdominal wall/pain in burned area [burns third degree], burn is worsening [condition aggravated], infected bad now [burn infection], burned a hole in my lower abdomen [wound], she will have a scar for the remainder of her life [scar] , applied heatwrap directly to skin/not able to read the instructions prior to usage as they were in french [device use error], it was getting too hot/wrap got a little bit uncomfortable (not hot burning) [device issue], used heatwrap for cramping on left side/patient informed that she bought thermacare lower back for lower abdomen pain [device use issue].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6)-year-old caucasian female patient with ethnicity hispanic/latino started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n31955, expiration date: mar2019, manufactured date: 18apr2016) from (b)(6) 2017 for "cramping on left side" and for pain in lower abdomen.The patient's medical history included menopause and never smoker.There were no concomitant medications.The patient lived in the usa.On (b)(6) 2017, she was on vacation in (b)(6) and applied the heatwrap directly to her skin between her left hip and pelvic area and went sightseeing for an unknown number of hours.She stated she kept shifting the wrap around if she felt it was getting too hot.The patient reported she was moving the heatwrap and her finger touched a burn area.She stated she did not feel anything "like oh my god i'm burning!", her thumb hit the burn when moving the heatwrap and that was how she knew she was burned.Burn to left hip area was reported as worsened on an unspecified date in (b)(6) 2017.The heatwrap had burned her skin pretty badly between her left hip and pelvic area.It wasn't as horrific at first as it is now.It was just a regular burn when she spoke to the pharmacist.She stated it was then getting infected on an unspecified date in (b)(6) 2017.The patient mentioned the product was purchased in (b)(6) while on vacation and the burn occurred when in (b)(6) as well.She stated she had not been to an md regarding this burn as she was on vacation, but may go.While in (b)(6), the patient did consult a pharmacist that recommended a burn cream called biafine trolamine.The patient further reported that the product's instructions stated that each patch can be worn for a 16-hour time frame.However, after approximately 4 to 5 hours, she noticed a severe burning sensation in the section of her abdomen/burn of abdominal wall where she had applied the patch.She removed the patch and was horrified to find out that the patch had burned a hole in her lower abdomen on (b)(6) 2017.As a result of the pain associated with the burn caused by your product, her vacation was ruined.Since returning home she had to consult with a physician four times regarding the injury caused by the product.She had been diagnosed as suffering a third degree burn on her stomach (groin area)/ burn of groin and she will have a scar (2017) for the remainder of her life.Patient with small 3rd burn left lower abdomen due to heating injury in insensate skin of abdominoplasty flap.Wound was healing well with silvadene dressing.Other treatment includes: silver sulfadiazine (silvadene/thermazene) 1 % topical cream, cephalexin (keflex) 500 mg oral capsules.The patient stated "i am writing directly to you in order to inform you of your products defectiveness and also to obtain compensation for the pain, suffering, life time sore, and medical expenses that i have and will incur in connection with this injury.I was advised by my doctor to write to you directly, prior to obtaining legal counsel.However, time is of the essence in resolving this matter.As such, unless you reply to my request within thirty days from the date of this letter, i will retain counsel to represent me in this matter." she had lab data on an unspecified date which included blood pressure: 136/78 mmhg; pulse: 72; temperature (src): 98 degree f (36.7 degree c) (tympanic); respiratory rate: 16; weight (wt): (b)(6), body mass index: (b)(6); body surface area: (b)(6).Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.The patient assessed her skin tone as fair.The patient is not currently under the care of a physician for any medical conditions.She denied having sensitive skin or any abnormal skin conditions.The patient had not previously used thermacare heatwraps.She had previously used a heating pad with no problems experienced.The patient was wearing underwear and pants over the wrap as well as a shirt and jacket (reported as "nothing heavy or bulky").She did not engage in exercise while using the heatwrap.She checked her skin frequently during use.The patient was not able to read the instructions prior to usage as they were in french.She stated she looked at the pictures on the box and did what it said.The patient used the wrap over healthy skin and over the correct part of the body.She did not overlap the wrap and did not apply any pressure over the wrap.The patient has discarded the wrap she was wearing when the burn occurred.There was no damage to the packaging and the heatwraps were sealed appropriately.Clinical outcome of the events third degree burns, burn is worsening, infected bad now, burned a hole in my lower abdomen was resolving.Clinical outcome of the other events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Visual inspection of a retain sample included one carton and the two pouched wraps inside shows no obvious defects.Review of the batch device history record for this batch concludes all release requirements were met.The review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the two day run report a total of (b)(4) wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature in process limits.A total of (b)(4) pti (pouch leak) tests were performed with no failures.The shift production record was reviewed, there were no mention of incidents during manufacturing that would affect wrap temperature.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.After a review of the batch thermal records, thermal results all met product release criteria.The product effect may vary with each individual.Final confirmation status was reported as not confirmed.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2017): new information received from a contactable consumer includes: ethnicity, indication, medical history, lab data, more events treatment information.Added new events "burned a hole in my lower abdomen", "she would have a scar for the remainder of her life".Updated event term "burn to left hip area" to "third degree burn on my stomach (groin area)/ burn to left hip area/burn of groin/burn of abdominal wall/pain in burned area", and coded from "thermal burn" to "burns third degree".Follow-up ((b)(6) 2017): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up ((b)(6) 2017): new information received from a contactable consumer includes: this female patient wore thermacare heatwrap (thermacare lower back & hip) approximately for 4 to 5 hours for cramps on (b)(6) 2017.She had previously used unknown heating products for pain relief on (b)(6) 2017 for 20 min with no problems experienced.She checked her skin every time it got too warm, she felt a very hot burn and when she looked at her skin it was already peeling off and little black granules/sand like things were on the burn on her skin.It was reported that only one little pouch broke and burned her skin.Alternatively it was reported that, she had third degree burn until approximately the week of (b)(6) 2017.It was also reported that her pain was gone and only a very ugly scar remained.On (b)(6) 2017, her physician examined her burn.She was treated with sulfadiazine silver (thermazene) and sulfadiazine silver (silvadene) since (b)(6) 2017 for the reported events.She also treated with cefalexin (keflex) antibiotic from (b)(6) 2017 to an unknown date for infection.As of (b)(6) 2017, the clinical outcome of the events she will have a scar for the remainder of her life was not resolved.Follow-up ((b)(6) 2017): this contactable consumer reported by way of consumer questionnaire.This female patient applied the thermacare heatwrap (thermacare lower back & hip) directly on the skin on left side between hip and groin like it shown on the package on (b)(6) 2017 and discontinued the product usage on the same day.The product was not heated in a microwave prior to usage and not re-heated during usage.She did not leave the product on while she was asleep.Her skin was not damaged or broken prior to usage of the product and there was no area bruised or swelled 48 hours prior to usage of the product.The patient did not detect irritation, redness or burning until the final burn.She had five visits to doctor for her third degree burn on left groin.She was under the care of a medical doctor until (b)(6) 2017.She received treatment until (b)(6) 2017.Follow-up attempts are completed.No further information is expected.All events occurred in a country different from that of the reporter.This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
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