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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Sweating (2444); Partial thickness (Second Degree) Burn (2694)

Event Date 10/24/2016

Event Type  Injury  

Event Description

Event verbatim [preferred term] second degree burn with no blister, burning bumps [burns second degree] , used the heatwrap for 23 hours, sleeping while wearing the heatwrap [intentional device misuse] , itchy [pruritus] , skin gets rashy on her back [rash] , sweaty underneath [hyperhidrosis] , events reported as worsened [condition aggravated] ,.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) from (b)(6) 2016 for lower back pain.Medical history included a hysterectomy from an unknown date in 2015 and menopause from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient reported she wore the product for 23 hours from (b)(6) 2016.She applied the wrap at 9:00 a.M.On (b)(6) 2016.She stated there was itching while she was using the heatwrap on her lower back.The patient reported she checked the skin under the wrap two or three times.She stated she felt it, but did not see it.The patient reported she felt a burning sensation and thought the skin was sweaty underneath.She stated her lower back was burning and itching.The patient reported there were bumps there like how your skin gets red and rashy on her back.She removed the wrap on the morning of (b)(6) 2016, at 9:00 a.M., and mentioned it really hurt.The patient took a shower and put on hydrocortisone 1% ointment.She applied the ointment to soothe the itching and burning.The patient stated she had a second degree burn with no blister.She reported the burns were in the same place the heat cells were, they even had the same shape.The patient stated the events had worsened.The patient did not consult a healthcare professional as a result of the events.The patient assessed her skin tone as medium.She denied having sensitive skin and denied having any abnormal skin conditions.The patient was not taking any medications (including over the counter, herbal, nutritional or any applied to the skin) during the time the events were experienced.She did not engage in exercise while using the heatwrap and read the usage instructions prior to using the heatwrap.The patient was not wearing several layers of clothing over the heatwrap and denied wearing a snug waistband/belt or similar or otherwise applied pressure over the area during wrap usage.She denied previously using other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The patient denied having any of the following conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on skin, rheumatoid arthritis, decreased sensation and neuropathy.The patient mentioned she still has the used wraps but the product packaging was discarded.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included hydrocortisone 1% ointment.Clinical outcome of the events 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 event "intentional device misuse and a second degree burn " as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability., comment: based on the information provided, the event "intentional device misuse and a second degree burn " as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Second degree burn with no blister, burning bumps [burns second degree] , used the heatwrap for 23 hours, sleeping while wearing the heatwrap [intentional device misuse] , itchy [pruritus] , skin gets rashy on her back [rash] , sweaty underneath [hyperhidrosis] , events reported as worsened [condition aggravated] ,.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) from (b)(6) 2016 for lower back pain.Medical history included a hysterectomy from an unknown date in 2015 and menopause from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient reported she wore the product for 23 hours from (b)(6) 2016.She applied the wrap at 9:00 a.M.On (b)(6) 2016.She stated there was itching while she was using the heatwrap on her lower back.The patient reported she checked the skin under the wrap two or three times.She stated she felt it, but did not see it.The patient reported she felt a burning sensation and thought the skin was sweaty underneath.She stated her lower back was burning and itching.The patient reported there were bumps there like how your skin gets red and rashy on her back.She removed the wrap on the morning of (b)(6) 2016, at 9:00 a.M., and mentioned it really hurt.The patient took a shower and put on hydrocortisone 1% ointment.She applied the ointment to soothe the itching and burning.The patient stated she had a second degree burn with no blister.She reported the burns were in the same place the heat cells were, they even had the same shape.The patient stated the events had worsened.The patient did not consult a healthcare professional as a result of the events.The patient assessed her skin tone as medium.She denied having sensitive skin and denied having any abnormal skin conditions.The patient was not taking any medications (including over the counter, herbal, nutritional or any applied to the skin) during the time the events were experienced.She did not engage in exercise while using the heatwrap and read the usage instructions prior to using the heatwrap.The patient was not wearing several layers of clothing over the heatwrap and denied wearing a snug waistband/belt or similar or otherwise applied pressure over the area during wrap usage.She denied previously using other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The patient denied having any of the following conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on skin, rheumatoid arthritis, decreased sensation and neuropathy.The patient mentioned she still has the used wraps but the product packaging was discarded.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included hydrocortisone 1% ointment.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: updated medical history onset date (hysterectomy: 2015).Company clinical evaluation comment based on the information provided, the event "intentional device misuse and a second degree burn " as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device., comment: based on the information provided, the event "intentional device misuse and a second degree burn " as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.

Manufacturer Narrative

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.

Event Description

Event verbatim [preferred term] second degree burn with no blister, burning bumps [burns second degree] , used the heatwrap for 23 hours, sleeping while wearing the heatwrap [intentional device misuse] , itchy [pruritus] , skin gets rashy on her back [rash] , sweaty underneath [hyperhidrosis] , events reported as worsened [condition aggravated].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A 50-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) from (b)(6) 2016 for lower back pain.Medical history included a hysterectomy from an unknown date in 2015 and menopause from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.The patient reported she wore the product for 23 hours from (b)(6) 2016.She applied the wrap at 9:00 a.M.On (b)(6) 2016.She stated there was itching while she was using the heatwrap on her lower back.The patient reported she checked the skin under the wrap two or three times.She stated she felt it, but did not see it.The patient reported she felt a burning sensation and thought the skin was sweaty underneath.She stated her lower back was burning and itching.The patient reported there were bumps there like how your skin gets red and rashy on her back.She removed the wrap on the morning of (b)(6) 2016, at 9:00 a.M., and mentioned it really hurt.The patient took a shower and put on hydrocortisone 1% ointment.She applied the ointment to soothe the itching and burning.The patient stated she had a second degree burn with no blister.She reported the burns were in the same place the heat cells were, they even had the same shape.The patient stated the events had worsened.The patient did not consult a healthcare professional as a result of the events.The patient assessed her skin tone as medium.She denied having sensitive skin and denied having any abnormal skin conditions.The patient was not taking any medications (including over the counter, herbal, nutritional or any applied to the skin) during the time the events were experienced.She did not engage in exercise while using the heatwrap and read the usage instructions prior to using the heatwrap.The patient was not wearing several layers of clothing over the heatwrap and denied wearing a snug waistband/belt or similar or otherwise applied pressure over the area during wrap usage.She denied previously using other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).The patient denied having any of the following conditions: diabetes, poor circulation, heart disease, difficulty feeling heat or pain on skin, rheumatoid arthritis, decreased sensation and neuropathy.The patient mentioned she still has the used wraps but the product packaging was discarded.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included hydrocortisone 1% ointment.The outcome of event used the heatwrap for 23 hours, sleeping while wearing the heatwrap was unknown.Clinical outcome of the other events was not resolved.Additional information received from product quality complaint (pqc) group included investigation results.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.Amendment: this follow-up report is being submitted to amend previously reported information: updated medical history onset date (hysterectomy: 2015).Follow-up (20dec2016): follow-up attempts are completed.No further information is expected.Follow-up (05mar2020): new information received from product quality complaints (pqc) group included: product quality investigation results., comment: based on the information provided, the event "intentional device misuse and a second degree burn" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.All events are 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.In the case narrative, there is evidence of intentional device misuse which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is 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: 6066698
• MDR Text Key: 58770876
• Report Number: 1066015-2016-00138
• 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
• Report Date: 10/25/2016

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/29/2016; 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 69