MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Date 02/10/2016

Event Type  Injury  

Event Description

Burned my skin,intense burning on my lower abdomen area [thermal burn].Blistered my skin [blister].Product burned me to the point of blister/bleeding [haemorrhage].Case description: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare menstrual), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient use menstrual hearing wraps every month.On (b)(6) 2016, she placed one on and went about her day.She kept it on for approximately 5 hours and didn't notice anything unusual while she was using it.In the evening while taking her shower she felt some intense burning on her lower abdomen area.The thermacare burned and blistered her skin, to the point of blister/bleeding.She had taken several pictures to document these burns.The outcome of the events 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 event "burned and blistered her skin, to the point of blister/bleeding" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event "burned and blistered her skin, to the point of blister/bleeding" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

Event Description

Case description: this is a spontaneous report from a contactable consumer.A (b)(6) year old female patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare menstrual), via an unspecified route of administration from an unspecified date for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient use menstrual heating wraps every month.On (b)(6) 2016, she placed one on and went about her day.She kept it on for approximately 5 hours and didn't notice anything unusual while she was using it.In the evening while taking her shower she felt some intense burning on her lower abdomen area.The thermacare burned and blistered her skin, to the point of blister/bleeding.She had taken several pictures to document these burns.She reported this was not something she could pay just to get a burn checked that she was able to clean (not specified) and take care of at home.The outcome of the events was unknown.The action taken with thermacare heatwrap was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (17feb2016): new information received from a contactable consumer included patient data (age) and treatment.Company clinical evaluation comment based on the information provided, the event "burned and blistered her skin, to the point of blister/bleeding" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets final (b)(6) and 30-day fda reportability case comment: based on the information provided, the event "burned and blistered her skin, to the point of blister/bleeding" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets final (b)(6) and 30-day fda reportability.

Event Description

Burned my skin,intense burning on my lower abdomen area/ burning on her skin [thermal burn].Blistered my skin/ blisters [blister].Product burned me to the point of blister/ bleeding [haemorrhage].Redness [erythema].Itching [pruritus].Oozing [wound secretion].Permanent scar [scar].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare menstrual) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient used menstrual heating wraps every month.On (b)(6) 2016, she applied one and went about her day.She kept it on for approximately 5 hours and didn't notice anything unusual while she was using it.In the evening while taking her shower she felt some intense burning on her lower abdominal area.The thermacare heatwrap burned and blistered her skin, to the point of blister/bleeding.She had taken several pictures to document these burns.She reported this was not something she could pay just to get a burn checked that she was able to clean (not specified) and take care of at home.Action taken with thermacare heatwrap was unknown.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (17feb2016): new information received from a contactable consumer includes: patient data (age) and treatment.Follow up activities completed.No further information expected.Follow-up (06jun2016): this contactable consumer reported by way of claim letter and consumer questionnaire.This female patient purchased thermacare heatwrap (thermacare menstrual) in (b)(6) 2016 and applied inside of her underwear in lower abdomen or pelvis from (b)(6) 2016 11 pm to (b)(6) 2016 7 am (8 hours) for menstrual pain/cramps.The relevant medical history included rheumatoid arthritis on an unknown date.The past drug history included thermacare heatwrap (thermacare menstrual) for many years and in (b)(6) 2016 for menstrual pain/cramps and never had an issue.She did not had any lotions, creams, ointments on her skin and did not had red, bruised, swollen, open or damaged/broken skin when she applied the wrap.On (b)(6) 2016, when she woke up at 7 am, removed the wrap and took shower.She felt burning on her skin, redness, itching, blisters, oozing and bleeding.On an unknown date, she had permanent scar.She did not feel the burns were severe enough to seek the medical help.She cleaned them with peroxide and applied neomycin/polymyxin b/bacitracin (neosporin) and band aids.As of (b)(6) 2016, the clinical outcome of the events burning on her skin was recovering, oozing, redness, itching, blisters and bleeding was recovered and permanent scar was not recovered.

Event Description

Event verbatim [preferred term]: burned my skin,intense burning on my lower abdomen area/ burning on her skin/blistered my skin/blisters [burns second degree], product burned me to the point of blister/ bleeding [haemorrhage], oozing [wound secretion], permanent scar [scar].Case narrative:this is a spontaneous report from a contactable consumer.A 44-year-old female patient started to use thermacare heatwrap (thermacare menstrual) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient used menstrual heating wraps every month.On (b)(6) 2016, she applied one and went about her day.She kept it on for approximately 5 hours and didn't notice anything unusual while she was using it.In the evening while taking her shower she felt some intense burning on her lower abdominal area.The thermacare heatwrap burned and blistered her skin, to the point of blister/bleeding.She had taken several pictures to document these burns.She reported this was not something she could pay just to get a burn checked that she was able to clean (not specified) and take care of at home.Action taken with thermacare heatwrap was unknown.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (17feb2016): new information received from a contactable consumer includes: patient data (age) and treatment.Follow up activities completed.No further information expected.Follow-up (06jun2016): this contactable consumer reported by way of claim letter and consumer questionnaire.This female patient purchased thermacare heatwrap (thermacare menstrual) in (b)(6) 2016 and applied inside of her underwear in lower abdomen or pelvis from (b)(6) 2016 11 pm to (b)(6) 2016 7 am (8 hours) for menstrual pain/cramps.The relevant medical history included rheumatoid arthritis on an unknown date.The past drug history included thermacare heatwrap (thermacare menstrual) for many years and in (b)(6) 2016 for menstrual pain/cramps and never had an issue.She did not had any lotions, creams, ointments on her skin and did not had red, bruised, swollen, open or damaged/broken skin when she applied the wrap.On (b)(6) 2016, when she woke up at 7 am, removed the wrap and took shower.She felt burning on her skin, redness, itching, blisters, oozing and bleeding.On an unknown date in 2016, she had permanent scar.She did not feel the burns were severe enough to seek the medical help.She cleaned them with peroxide and applied neomycin/polymyxin b/bacitracin (neosporin) and band aids.As of 06jun2016, the clinical outcome of the event "burned my skin,intense burning on my lower abdomen area/ burning on her skin/blistered my skin/ blisters" was recovering, the clinical outcome of the events "product burned me to the point of blister/ bleeding and oozing" was recovered in 2016 and "permanent scar" was not recovered.Amendment: this follow-up report is being submitted to amend previously reported information: device age populated as 8 hours, malfunction was left blank, the events "burn" and "blister" were combined to "burn blister", "redness and itching" were subsumed under "burn blister".

Event Description

Event verbatim [preferred term], burned my skin,intense burning on my lower abdomen area/ burning on her skin/blistered my skin/ blisters [burns second degree], product burned me to the point of blister/ bleeding [haemorrhage], wound oozing [wound secretion], permanent scar [scar], used heatwrap from (b)(6) 2016 11 pm to (b)(6) 2016 7 am (8 hours) while sleeping [device use error], narrative: this is a spontaneous report from a contactable consumer.A 44-year-old female patient started to use thermacare heatwrap (thermacare menstrual) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient used menstrual heating wraps every month.On (b)(6) 2016, she applied one and went about her day.She kept it on for approximately 5 hours and didn't notice anything unusual while she was using it.In the evening while taking her shower she felt some intense burning on her lower abdominal area.The thermacare heatwrap burned and blistered her skin, to the point of blister/bleeding.She had taken several pictures to document these burns.She reported this was not something she could pay just to get a burn checked that she was able to clean (not specified) and take care of at home.Action taken with thermacare heatwrap was unknown.Clinical outcome of the events was unknown.Per the product quality group: this investigation was conducted for an unknown lot number menstrual 8 hour product.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 citi customizable search returned a total of 76 complaints for menstrual 8hr products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.A citi complaint trend search was performed for the subclass 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 adverse event safety request for investigation for menstrual 8hr products.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 product quality related trend identified 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 (17feb2016): new information received from a contactable consumer includes: patient data (age) and treatment.Follow-up (06jun2016): this contactable consumer reported by way of claim letter and consumer questionnaire.This female patient purchased thermacare heatwrap (thermacare menstrual) in (b)(6) 2016 and applied inside of her underwear in lower abdomen or pelvis from (b)(6) 2016 11 pm to (b)(6) 2016 7 am (8 hours) for menstrual pain/cramps.The relevant medical history included rheumatoid arthritis on an unknown date.The past drug history included thermacare heatwrap (thermacare menstrual) for many years and in (b)(6) 2016 for menstrual pain/cramps and never had an issue.She did not use any lotions, creams, ointments on her skin and did not have red, bruised, swollen, open or damaged/broken skin when she applied the wrap.On (b)(6) 2016, when she woke up at 7 am, removed the wrap and took a shower.She felt burning on her skin, redness, itching, blisters, oozing and bleeding.On an unknown date in 2016, she had permanent scar.She did not feel the burns were severe enough to seek medical help.She cleaned them with peroxide and applied neomycin/polymyxin b/bacitracin (neosporin) and band aids.Clinical outcome of the event "burned my skin,intense burning on my lower abdomen area/ burning on her skin/blistered my skin/ blisters" was recovering.Clinical outcome of the events "product burned me to the point of blister/ bleeding and oozing" was recovered in 2016.Clinical outcome of event "permanent scar" was not recovered.Clinical outcome of remaining event was unknown.Amendment: this follow-up report is being submitted to amend previously reported information: device age populated as 8 hours, malfunction was left blank, the events "burn" and "blister" were combined to "burn blister", "redness and itching" were subsumed under "burn blister".Follow-up (29may2020): new information received from product quality group includes: investigation results; event added of device use error (used heatwrap from (b)(6) 2016 11 pm to (b)(6) 2016 7 am (8 hours) while sleeping).Follow up activities completed.No further information expected.

Manufacturer Narrative

This investigation was conducted for an unknown lot number menstrual 8 hour product.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 citi customizable search returned a total of 76 complaints for menstrual 8hr products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.A citi complaint trend search was performed for the subclass 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 adverse event safety request for investigation for menstrual 8hr products.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 product quality related trend identified 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.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 5444466
• MDR Text Key: 38480361
• Report Number: 1066015-2016-00024
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/06/2016; 06/06/2016
• Supplement Dates FDA Received: 03/01/2016; 06/15/2016; 02/13/2020; 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR