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

Lot Number LW87447

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Scar Tissue (2060); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 10/01/2018

Event Type  Injury  

Event Description

Two big burns on stomach, red and blistered [burns second degree], scar [scar].Case narrative: this is a spontaneous report from a contactable consumer reporting on behalf of her daughter.This (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual) (device lot number lw87447, expiration date mar2021) from an unspecified date for menstrual pain.The patient's medical history was not reported.There were no concomitant medications.The patient previously used thermacare heatwraps on an unspecified date a couple months ago with no adverse effect.On an unspecified date in (b)(6) 2018, the reporter stated she was going through her voicemail that she received on (b)(6) 2018, saying something about thermacare heatwrap menstrual, that it should not be used because something is leaking and can cause burns.Her daughter used it at the beginning of the month, went to school, and there were two big burns on her stomach.The caller stated her daughter noticed the burning while at school probably sometime between 0700 and 1430.The product was applied sometime around 0700 and when her daughter came home, before 1430, the heatwrap was off.She took off the heatwrap and noticed the skin had burns, like red and blistered.The mother thought it was maybe because her daughter wore jeans or maybe her panties.The patient was wearing a pair of jeans that were stretch, no zipper, belt or buttons.She checked the skin under the heatwrap frequently during use.After the heatwrap started burning, her daughter saw the blister and took it off.She has improved, but there are scars.The patient discarded the product box with the wrap inside.Therapeutic measures taken included neosporin.The patient is currently under the care of a psychiatrist.The patient did not consult a healthcare professional as a result of the events.The patient assessed her skin tone as medium (neither light nor dark).She did not have sensitive skin or abnormal skin conditions, but reported she has dark spots in some places.The patient denied having diabetes, poor circulation, heart disease, difficulty feeling heat or pain on her skin, rheumatoid arthritis, decreased sensation and neuropathy.The color of the box was red.There was no product remaining; however, the caller stated they have an unopened box.The patient had not previously used other heat products for pain relief such as an electric heating pad, hot water bottle or microwave gel pack.She did not engage in exercise while using the heatwrap and had read the usage instructions prior to heatwrap usage.The patient was not taking any medications including over the counter, herbal, nutritional or anything applied to the skin during the time the events were experienced.The packaging was sealed and intact at purchase.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6) 2018.Therapeutic measures taken included application of neosporin.No surgical intervention was required as a result of the events.Clinical outcome of the event burn blister was resolving with sequelae.Clinical outcome of the event scar was not resolved.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 blisters" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "scar" is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Two big burns on stomach, red and blistered [burns second degree], scar [scar].Case narrative: this is a spontaneous report from a contactable consumer reporting on behalf of her daughter.This (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual) from an unspecified date for menstrual pain.The patient's medical history was not reported.There were no concomitant medications.The patient previously used thermacare heatwraps on an unspecified date a couple months ago with no adverse effect.On an unspecified date in (b)(6) 2018, the reporter stated she was going through her voicemail that she received on (b)(6) 2018, saying something about thermacare heatwrap menstrual, that it should not be used because something is leaking and can cause burns.Her daughter used it at the beginning of the month, went to school, and there were two big burns on her stomach.The caller stated her daughter noticed the burning while at school probably sometime between 0700 and 1430.The product was applied sometime around 0700 and when her daughter came home, before 1430, the heatwrap was off.She took off the heatwrap and noticed the skin had burns, like red and blistered.The mother thought it was maybe because her daughter wore jeans or maybe her panties.The patient was wearing a pair of jeans that were stretch, no zipper, belt or buttons.She checked the skin under the heatwrap frequently during use.After the heatwrap started burning, her daughter saw the blister and took it off.She has improved, but there are scars.The patient discarded the product box with the wrap inside.Therapeutic measures taken included neosporin.The patient is currently under the care of a psychiatrist.The patient did not consult a healthcare professional as a result of the events.The patient assessed her skin tone as medium (neither light nor dark).She did not have sensitive skin or abnormal skin conditions, but reported she has dark spots in some places.The patient denied having diabetes, poor circulation, heart disease, difficulty feeling heat or pain on her skin, rheumatoid arthritis, decreased sensation and neuropathy.The color of the box was red.There was no product remaining; however, the caller stated they have an unopened box.The patient had not previously used other heat products for pain relief such as an electric heating pad, hot water bottle or microwave gel pack.She did not engage in exercise while using the heatwrap and had read the usage instructions prior to heatwrap usage.The patient was not taking any medications including over the counter, herbal, nutritional or anything applied to the skin during the time the events were experienced.The packaging was sealed and intact at purchase.Action taken with the suspect product was permanently withdrawn on an unspecified date in (b)(6) 2018.Therapeutic measures taken included application of neosporin.No surgical intervention was required as a result of the events.Clinical outcome of the event burn blister was resolving with sequelae.Clinical outcome of the event scar was not resolved.According to product quality complaint group: the root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.Our 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 (19dec2018): new information received from product quality complaints group included: investigation results.Company clinical evaluation comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "scar" is 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., comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event "scar" is 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.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.Our 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: 8041855
• MDR Text Key: 126307008
• Report Number: 1066015-2018-00142
• 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
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2021
• Device Lot Number: LW87447
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 90