MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Device Problems Temperature Problem (3022); Excessive Heating (4030)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Got burned with blister, burn that was a blister and a red spot [burns second degree].Heatwrap got so warm [product quality issue].Case description: this is a spontaneous report from a contactable consumer who reported on behalf of her sister.This (b)(6) year-old caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date for pain in her back.Medical history included macular degeneration from an unknown date and unknown if ongoing was diagnosed with macular degeneration about 5 years ago and sees her specialist every 4 months and receives injections right in her eyeballs.The patient's concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in 2013 for an unspecified indication with no adverse effect.On an unspecified date in 2014, the reporter stated her sister used the heatwrap for approximately 2 to 3 hours and it got so warm she got burned with a blister.The reporter stated she checked her sister's skin and noticed a burn that was a blister and a red spot and removed the thermacare heatwrap.She mentioned they did not contact her sister's doctor about the burn.She indicated she does not have the lot number, ndc or expiration date for the suspect product as it was a year ago and she has since thrown out all of the wraps and packaging.The patient's skin tone was assessed as very light or fair.She denied having any health problems such as diabetes, rheumatoid arthritis, decreased sensation, poor circulation, heart disease or neuropathy.The patient did not have sensitive skin or any abnormal skin conditions.She did not exercise while using the heatwrap and did not apply any pressure over the wrap.The patient denied sleeping while wearing the product and did not wear more than 2 layers of clothing over the wrap.She mentioned she read the usage instructions before using the heatwrap and checked the skin under the wrap frequently during use.The patient used a heating pad in the past without any adverse effects.Action taken with the suspect product was unknown.Therapeutic measures taken included an unspecified sav, neosporin and bandages to the burn for about a week.Clinical outcome of the event was resolved on an unspecified date in 2014.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the event burn second degree and heatwrap got so warm as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, 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 burn second degree and heatwrap got so warm as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Case description: this is a spontaneous report from a contactable consumer who reported on behalf of her sister.This (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date for pain in her back.Medical history included macular degeneration from an unknown date and unknown if ongoing was diagnosed with macular degeneration about 5 years ago and sees her specialist every 4 months and receives injections right in her eyeballs.The patient's concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in 2013 for an unspecified indication with no adverse effect.On an unspecified date in 2014, the reporter stated her sister used the heatwrap for approximately 2 to 3 hours and it got so warm she got burned with a blister.The reporter stated she checked her sister's skin and noticed a burn that was a blister and a red spot and removed the thermacare heatwrap.She mentioned they did not contact her sister's doctor about the burn.She indicated she does not have the lot number, ndc or expiration date for the suspect product as it was a year ago and she has since thrown out all of the wraps and packaging.The patient's skin tone was assessed as very light or fair.She denied having any health problems such as diabetes, rheumatoid arthritis, decreased sensation, poor circulation, heart disease or neuropathy.The patient did not have sensitive skin or any abnormal skin conditions.She did not exercise while using the heatwrap and did not apply any pressure over the wrap.The patient denied sleeping while wearing the product and did not wear more than 2 layers of clothing over the wrap.She mentioned she read the usage instructions before using the heatwrap and checked the skin under the wrap frequently during use.The patient used a heating pad in the past without any adverse effects.Action taken with the suspect product was unknown.Therapeutic measures taken included an unspecified sav, neosporin and bandages to the burn for about a week.Clinical outcome of the event was resolved on an unspecified date in 2014.Additional information has been requested and will be provided as it becomes available.Follow-up (14oct2015): new information received from a contactable physician includes: the physician denied being provided information regarding an adverse event with use of the product and could not confirm occurrence of the events reported by the patient.Company clinical evaluation comment based on the information provided, the event burn second degree and heatwrap got so warm as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event burn second degree and heatwrap got so warm as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets follow up10-day eu and 30-day fda reportability.

Event Description

Event verbatim [preferred term].Got burned with blister, burn that was a blister and a red spot [burns second degree], heatwrap got so warm [device issue].Narrative: this is a spontaneous report from a contactable consumer who reported on behalf of her sister.This 80-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date for pain in her back.Medical history included macular degeneration from an unknown date and unknown if ongoing; was diagnosed with macular degeneration about 5 years ago and sees her specialist every 4 months and receives injections right in her eyeballs.The patient's concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in 2013 for an unspecified indication with no adverse effect.On an unspecified date in 2014, the reporter stated her sister used the heatwrap for approximately 2 to 3 hours and it got so warm she got burned with a blister.The reporter stated she checked her sister's skin and noticed a burn that was a blister and a red spot and removed the thermacare heatwrap.She mentioned they did not contact her sister's doctor about the burn.She indicated she does not have the lot number, ndc or expiration date for the suspect product as it was a year ago and she has since thrown out all of the wraps and packaging.A sample was not available to be returned.The patient's skin tone was assessed as very light or fair.She denied having any health problems such as diabetes, rheumatoid arthritis, decreased sensation, poor circulation, heart disease or neuropathy.The patient did not have sensitive skin or any abnormal skin conditions.She did not exercise while using the heatwrap and did not apply any pressure over the wrap.The patient denied sleeping while wearing the product and did not wear more than 2 layers of clothing over the wrap.She mentioned she read the usage instructions before using the heatwrap and checked the skin under the wrap frequently during use.The patient used a heating pad in the past without any adverse effects.Action taken with the suspect product was unknown.Therapeutic measures taken included an unspecified sav, neosporin and bandages to the burn for about a week.Clinical outcome of the event was resolved on an unspecified date in 2014.Product quality complaints provided the following investigation information: an investigation conducted for an unknown lot number lower back/hip (lbh) 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 available for evaluation.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.No 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 and visual inspection, to ensure product quality.There was no reasonable suggestion of device malfunction.Follow-up (14oct2015): new information received from a contactable physician includes: the physician denied being provided information regarding an adverse event with use of the product and could not confirm occurrence of the events reported by the patient.Follow-up (15apr2020): new information from product quality complaints includes investigation results.Additionally, the following information was amended: updated event (from product quality issue to device issue).Follow-up attempts are completed.No further information is expected.Comment: based on the information provided, the event burn second degree and heatwrap got so warm as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, 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.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The root cause category is non-assignable (complaint not confirmed as a quality defect).No further investigations or actions are suggested at this time.

Manufacturer Narrative

An investigation conducted for an unknown lot number lower back/hip (lbh) 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 available for evaluation.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.No 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 and visual inspection, to ensure product quality.There was no reasonable suggestion of device malfunction.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: 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, 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.

Event Description

Event verbatim [preferred term].Got burned with blister, burn that was a blister and a red spot [burns second degree], heatwrap got so warm [device issue].Narrative: this is a spontaneous report from a contactable consumer who reported on behalf of her sister.This 80-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date for pain in her back.Medical history included she was diagnosed with macular degeneration about 5 years before (in 2010) and sees her specialist every 4 months and receives injections right in her eyeballs.The patient's concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in 2013 for an unspecified indication with no adverse effect.On an unspecified date in 2014, the reporter stated her sister used the heatwrap for approximately 2 to 3 hours and it got so warm she got burned with a blister.The reporter stated she checked her sister's skin and noticed a burn that was a blister and a red spot and removed the thermacare heatwrap.She mentioned they did not contact her sister's doctor about the burn.She indicated she does not have the lot number, ndc or expiration date for the suspect product as it was a year ago and she has since thrown out all of the wraps and packaging.A sample was not available to be returned.The patient's skin tone was assessed as very light or fair.She denied having any health problems such as diabetes, rheumatoid arthritis, decreased sensation, poor circulation, heart disease or neuropathy.The patient did not have sensitive skin or any abnormal skin conditions.She did not exercise while using the heatwrap and did not apply any pressure over the wrap.The patient denied sleeping while wearing the product and did not wear more than 2 layers of clothing over the wrap.She mentioned she read the usage instructions before using the heatwrap and checked the skin under the wrap frequently during use.The patient used a heating pad in the past without any adverse effects.Action taken with the suspect product was unknown.Therapeutic measures taken included an unspecified sav, neosporin and bandages to the burn for about a week.Clinical outcome of the event was resolved on an unspecified date in 2014.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: 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, 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.The sample had not been received by the site.Follow-up (14oct2015): new information received from a contactable physician includes: the physician denied being provided information regarding an adverse event with use of the product and could not confirm occurrence of the events reported by the patient.Follow-up (15apr2020): new information from product quality complaints includes investigation results.Additionally, the following information was amended: updated event (from product quality issue to device issue).Follow-up attempts are completed.No further information is expected.Follow up (22may2020): new information from product quality complaints includes updated investigation results.Comment: based on the information provided, the event burn second degree and heatwrap got so warm as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, 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.A manufacturing and technical assessment not complete for the wrap involved in this case due to an unspecified batch reference number.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The root cause category is non-assignable (complaint not confirmed as a quality defect).No further investigations or actions are suggested at this time.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 5114269
• MDR Text Key: 27148993
• Report Number: 1066015-2015-00127
• 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,health professional
• Type of Report: Followup,Followup,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 54