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

Lot Number T48928

Device Problem Insufficient Information (3190)

Patient Problems Rheumatoid Arthritis (1724); Neuropathy (1983); Scarring (2061); Burn, Thermal (2530)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Two double burn marks/hurts [thermal burn], burn mark was scarring over [scar], she was wearing a snug waistband/bet or similar or other wise applied pressure over the area/ she did not check her skin under the product while wearing thermacare [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) -year-old (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date at an unspecified frequency for back hurts all the time.Medical history included ongoing back pain.There were no concomitant medications.She has been using thermacare heatwraps for many years for an unspecified indication and did not experience problem/symptom during previous use.She previously used electric heating pad for pain relief, always used the heating pad, especially in the winter, confirmed did not use when went on vacation and did not experience problem/symptom during previous use.On (b)(6) 2018 she applied one prior to getting on the airplane to fly from (location withheld) to (location withheld).It was on from 4 in the evening around 4:45pm when left from (location withheld) and removed around 11:30pm (location withheld) time.She had it on then approximately 6-7 hours.She applied it to her lower back.She had on a turtle neck shirt that was tucked in, applied the thermacare wrap, and had the sweatshirt on over that.When she got to her son's house taking her clothes off to put on pajamas noticed something did not feel right.She saw two burn marks, it burned her right though her shirt.The two double burn marks were located right above her left buttocks and the heatwrap was not touching her skin.She did not even feel it get warm so shocked when saw the burn marks.The first night it hurt really badly to get in the shower.It still hurt.Now the burn mark was scarring over, but it melted her.When she wears pants, like jeans she has to tuck it back if it touches her it will hurt.If she wears dress pants it does not hurt, guess that is so because those are soft.She denied any lab investigation.She was currently under the care of a physician for back pain.She did not have diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy.She described her skin tone as fair.She did not have sensitive skin.She did not have any abnormal skin conditions.She was wearing several layers of clothing over the thermacare product.She was wearing a snug waistband/bet or similar or other wise applied pressure over the area.Stated did not attach to body or clothing; it is like velcro wrap.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare.She stated the very first time she read the usage instructions on thermacare when initially started to use product.However, this time she did not because she knew how to apply it and had used it before.She did not consult a healthcare professional for the problem/symptom.She no longer has heat wrap that did not feel warm up and caused burn.She only had the wrap that was not used.The action taken in response to the event for thermacare heatwrap was unknown.Therapeutic treatment for two double burn marks included neosporin, she applied it ten times a day when first occurred.She reported that two double burn marks was still ongoing, but better now, stating to scar over.The outcome of two double burn marks/hurts was resolving.The outcome of other 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 events of thermal burn, scar, and intentional device misuse 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 thermal burn, scar, and intentional device misuse 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.

Manufacturer Narrative

The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically, ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Site sample status: not received.

Event Description

Event verbatim [preferred term] two double burn marks/hurts [thermal burn] , burn mark was scarring over [scar] , she was wearing a snug waistband/bet or similar or other wise applied pressure over the area/ she did not check her skin under the product while wearing thermacare [intentional device misuse].Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 48-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date at an unspecified frequency for back hurts all the time.Medical history included ongoing back pain.There were no concomitant medications.She has been using thermacare heatwraps for many years for an unspecified indication and did not experience problem/symptom during previous use.She previously used electric heating pad for pain relief, always used the heating pad, especially in the winter, confirmed did not use when went on vacation and did not experience problem/symptom during previous use.On (b)(6) 2018 she applied one prior to getting on the airplane to fly from (location withheld) to (location withheld).It was on from 4 in the evening around 4:45pm when left from (location withheld) and removed around 11:30pm (location withheld) time.She had it on then approximately 6-7 hours.She applied it to her lower back.She had on a turtle neck shirt that was tucked in, applied the thermacare wrap, and had the sweatshirt on over that.When she got to her son's house taking her clothes off to put on pajamas noticed something did not feel right.She saw two burn marks, it burned her right though her shirt.The two double burn marks were located right above her left buttocks and the heatwrap was not touching her skin.She did not even feel it get warm so shocked when saw the burn marks.The first night it hurt really badly to get in the shower.It still hurt.Now in (b)(6) 2018 the burn mark was scarring over, but it melted her.When she wears pants, like jeans she has to tuck it back if it touches her it will hurt.If she wears dress pants it does not hurt, guess that is so because those are soft.She denied any lab investigation.She was currently under the care of a physician for back pain.She did not have diabetes, poor circulation, heart disease, difficulty feeling heat or pain on your skin, rheumatoid arthritis, decreased sensation, neuropathy.She described her skin tone as fair.She did not have sensitive skin.She did not have any abnormal skin conditions.She was wearing several layers of clothing over the thermacare product.She was wearing a snug waistband/bet or similar or other wise applied pressure over the area.Stated did not attach to body or clothing; it is like velcro wrap.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare on (b)(6) 2018.She stated the very first time she read the usage instructions on thermacare when initially started to use product.However, this time she did not because she knew how to apply it and had used it before.She did not consult a healthcare professional for the problem/symptom.The device was not available for evaluation as she no longer has heat wrap that did not feel warm up and caused burn.She only had the wrap that was not used.The action taken in response to the event for thermacare heatwrap was unknown.Therapeutic treatment for two double burn marks included neosporin, she applied it ten times a day when first occurred, and a bandage.She reported that two double burn marks was still ongoing, but better now, stating to scar over.The outcome of two double burn marks/hurts was resolving.The outcome of other events was unknown.Investigations summary is as follows: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically, ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1: no harm to customer.Site sample status: not received.Follow-up attempts are completed.No further information is expected.Follow-up (24mar2020): new information from a product quality complaint group includes additional treatment of the event (bandage) from the consumer and summary of investigation., comment: based on the information provided, the events of thermal burn, scar, and intentional device misuse 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.The company conducted an investigation, the root cause for this event was identified, corrective action was implemented, and no further action is recommended.

• 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: 7259132
• MDR Text Key: 99569653
• Report Number: 1066015-2018-00018
• 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: 01/30/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Lot Number: T48928
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 71