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

Lot Number T98298

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Discharge (2225); Partial thickness (Second Degree) Burn (2694)

Event Date 10/28/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] burn on her lower back near her right hip that is raw and oozing after a layer of skin was removed/starting to blister and when she took the belt off [burns second degree], she did not check her skin under the product while wearing thermacare/used for 8 hours while sleeping, directly on the skin of the lower back near the hip [intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6) female patient, non-pregnant, post-menopausal, started to receive thermacare heatwrap (thermacare lower back & hip), device lot number t98298, expiration date jan2021, (b)(4), on (b)(6) 2018 applied 1 heat wrap to her back for 8 hours for back pain.Medical history included diabetes and poor circulation.She was under the care of a physician for pain, cholesterol, bipolar, diabetes, palpitation, mild mitral valve doesn't shut all the way.She also had back surgery and when she did a lot her back hurts so she used these wraps.Concomitant medications included daily medications (unspecified).The patient previously used thermacare heatwrap and did not experience any adverse event.She also previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experience any adverse event.The patient used thermacare back pain therapy advanced l/xl heat wrap and experienced burn on her lower back near her right hip that was raw and oozing after a layer of skin was removed.She said a cell burnt her back after leaving it on for 8 hours while sleeping directly on her lower back near her right hip.A layer of was removed when she took the belt off on morning of (b)(6) 2018 leaving a raw, oozing area.The event started between (b)(6) 2018 evening and (b)(6) 2018 morning.She further reported burn on lower back near the right hip, starting to blister and when she took the belt off, the top layer of skin came off where one of the heat cells was at.When she touched the area with her finger it was raw and burned, it is oozing a bit as well.She put (b)(6) and a big bandage over the burn on the morning of (b)(6) 2018 when she noticed the layer of skin was missing and oozing.The wraps says 16 hours of relief, wear for 8 hours and it continues to work for 8 hours after.She wore heat wraps before and this was the first time ever she got burnt.No lab data was provided.The patient classified her skin tone as medium (neither light nor dark).She did not have sensitive skin and abnormal skin conditions.She used for 8 hours while sleeping, directly on the skin of the lower back near the hip.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.She did not consult a healthcare professional for the problem(s)/symptom(s).She disposed of the faulty one, only has one unused wrap left.Packaging was sealed and intact.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of the event burn on her lower back near her right hip that is raw and oozing after a layer of skin was removed/starting to blister and when she took the belt off was not resolved.The outcome of other event was unknown.Company clinical evaluation comment: based on the information provided, the events of "burn blister 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 "burn blister 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 category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she "a cell burnt her back after leaving it on for 8 hours while sleeping directly on her lower back ".The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.Care should be taken when using the device following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] burn on her lower back near her right hip that is raw and oozing after a layer of skin was removed/starting to blister and when she took the belt off [burns second degree] , she did not check her skin under the product while wearing thermacare/used for 8 hours while sleeping, directly on the skin of the lower back near the hip [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).A 62-year-old female patient non-pregnant, post-menopausal, started to receive thermacare heatwrap (thermacare lower back & hip) (device lot number t98298, expiration date jan2021, upc number: 0573301003) on 28oct2018 applied 1 heat wrap to her back for 8 hours for back pain.Medical history included diabetes and poor circulation.She was under the care of a physician for pain, cholesterol, bipolar, diabetes, palpitation, mild mitral valve doesn't shut all the way.She also had back surgery and when she did a lot her back hurts so she used these wraps.Concomitant medications included daily medications (unspecified).The patient previously used thermacare heatwrap and did not experience any adverse event.She also previously used other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack) and did not experience any adverse event.The patient used thermacare back pain therapy advanced l/xl heat wrap and experienced burn on her lower back near her right hip that was raw and oozing after a layer of skin was removed.She said a cell burnt her back after leaving it on for 8 hours while sleeping directly on her lower back near her right hip.A layer of was removed when she took the belt off on morning of (b)(6) 2018 leaving a raw, oozing area.The event started between (b)(6) 2018 evening and (b)(6) 2018 morning.She further reported burn on lower back near the right hip, starting to blister and when she took the belt off, the top layer of skin came off where one of the heat cells was at.When she touched the area with her finger it was raw and burned, it is oozing a bit as well.She put neosporin and a big bandage over the burn on the morning of (b)(6) 2018 when she noticed the layer of skin was missing and oozing.The wraps says 16 hours of relief, wear for 8 hours and it continues to work for 8 hours after.She wore heat wraps before and this was the first time ever she got burnt.No lab data was provided.The patient classified her skin tone as medium (neither light nor dark).She did not have sensitive skin and abnormal skin conditions.She used for 8 hours while sleeping, directly on the skin of the lower back near the hip.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare.She read the usage instructions on thermacare before she used the product.She did not consult a healthcare professional for the problem(s)/symptom(s).She disposed of the faulty one, only has one unused wrap left.Packaging was sealed and intact.Action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of the event burn on her lower back near her right hip that is raw and oozing after a layer of skin was removed/starting to blister and when she took the belt off was not resolved.The outcome of other event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she "a cell burnt her back after leaving it on for 8 hours while sleeping directly on her lower back ".The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.Care should be taken when using the device following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (07dec2018): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment based on the information provided, the events of "burn blister" 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 review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events of "burn blister" 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 review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.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: 8047049
• MDR Text Key: 126512496
• Report Number: 1066015-2018-00145
• 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: 10/29/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2021
• Device Lot Number: T98298
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 77