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

Lot Number H09901

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Peeling (1999); Scarring (2061); Partial thickness (Second Degree) Burn (2694)

Event Date 04/02/2016

Event Type  Injury  

Event Description

Burn with blisters on thermacare application site, accompanied by pain, skin red, red spots [burns second degree], skin peeling off [skin exfoliation], scarring and presented a dark color [scar], scarring and presented a dark color [skin discolouration], body temperature increase [body temperature increased].Case description: this is a spontaneous report from a contactable nurse.An (b)(6) female patient of an unspecified ethnicity received thermacare heatwrap (thermacare lower back & hip), lot h09901, expire date may2016), first use, via topical on (b)(6) 2016 at 1 dose single for pain.The heatwrap was applied by the reporting nurse, over a layer of clothing (cotton sweater).The nurse confirmed that the patient hadn't been lying over the heatwrap nor had made any pressure on the heatwrap.Medical history included ongoing diabetes insulin-dependent, cardiac disease, circulation problems and thyroid disease.The patient has no prior history of rheumatoid arthritis, neuropathy of allergic skin reactions.Concomitant medications included levothyroxine sodium (euthyrox) for thyroid disease, allopurinol (allopurinol), acetylsalicylic acid (tromalyt) for cardiac disease and insulin (insulin) for diabetes.On (b)(6) 2016, during application of thermacare heatwrap, the patient experienced burn with blisters on thermacare application site, accompanied by pain as well as body temperature increase (up to 39ºc.The patient initially experienced red spots on the thermacare application site, which evolved to blisters (some bursting) and skin peeling off.The heatwrap was applied only during 4,5h.The nurse verified periodically the patient's skin and body during the application, and noticed the body temperature increase (from 37ºc up to 39ºc) and the skin becoming red, so took off the heatwrap at the end of 4,5h of application.The patient was observed at the hospital emergency department as a result of the events.The patient was not hospitalized.At the hospital, on (b)(6) 2016, the patient underwent tests and procedures which included, chest x-ray and blood test, both normal.In the absence of other causes, the events were attributed to the thermacare heatwrap use.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Therapeutic measures were taken as a result of burn with blisters on thermacare application site accompanied by pain, and included topical application of physiological saline solution and trolamine (biafine).The patient was recovered from body temperature increase, was recovering from the events burn with blister, skin peeling off, scarring and presented a dark color.The patient still experienced some pain on the area.The reporting nurse expects the patient to experience long-term sequelae such as scarring.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 blister accompanied by pain, skin red, red spots and skin peeling off 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.The events of skin scarring and presented dark color, and body temperature increased are non-serious and 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 blister accompanied by pain, skin red, red spots and skin peeling off 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.The events of skin scarring and presented dark color, and body temperature increased are non-serious and assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Burn with blisters on thermacare application site, accompanied by pain, skin red, red spots [burns second degree]; skin peeling off [skin exfoliation]; scarring and presented a dark color [scar]; scarring and presented a dark color [skin discolouration]; body temperature increase [body temperature increased]; scabs from the burning wound [scab].Case description: this is a spontaneous report from a contactable nurse.An (b)(6) female patient of an unspecified ethnicity received thermacare heatwrap (thermacare lower back & hip), lot h09901, expire date may2016), first use, via topical on (b)(6) 2016 at 1 dose single for pain.The heatwrap was applied by the reporting nurse, over a layer of clothing (cotton sweater).The nurse confirmed that the patient hadn't been lying over the heatwrap nor had made any pressure on the heatwrap.Medical history included ongoing diabetes insulin-dependent, cardiac disease, circulation problems and thyroid disease.The patient has no prior history of rheumatoid arthritis, neuropathy of allergic skin reactions.Concomitant medications included levothyroxine sodium (euthyrox) for thyroid disease, allopurinol (allopurinol), acetylsalicylic acid (tromalyt) for cardiac disease and insulin (insulin) for diabetes.On (b)(6) 2016, during application of thermacare heatwrap, the patient experienced burn with blisters on thermacare application site, accompanied by pain as well as body temperature increase (up to 39ºc).The patient initially experienced red spots on the thermacare application site, which evolved to blisters (some bursting) and skin peeling off.The heatwrap was applied only during 4,5h.The nurse verified periodically the patient's skin and body during the application, and noticed the body temperature increase (from 37ºc up to 39ºc) and the skin becoming red, so took off the heatwrap at the end of 4,5h of application.The patient was observed at the hospital emergency department as a result of the events.The patient was not hospitalized.At the hospital, on (b)(6) 2016, the patient underwent tests and procedures which included, chest x-ray and blood test, both normal.In the absence of other causes, the events were attributed to the thermacare heatwrap use.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Therapeutic measures were taken as a result of burn with blisters on thermacare application site accompanied by pain, and included topical application of physiological saline solution and trolamine (biafine).The patient was recovered from body temperature increase, the scabs from the burning wound fell off on (b)(6) 2016.The patient now presents scars with discoloration.The patient recovered with sequelae from burn with blisters on (b)(6) 2016 and recovered from skin peeling on an unspecified date.The patient is not recovered from scar and skin discoloration.The patient still experienced some pain on the area.The reporting nurse expects the patient to experience long-term sequelae such as scarring.Additional information has been requested and will be provided as it becomes available.Follow-up (22apr2016): new information received from a contactable nurse included reaction data (additional event of scab and the outcome of events).Company clinical evaluation comment: based on the information provided, the event burn blister accompanied by pain, skin red, red spots and skin peeling off 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.The events of skin scarring and presented dark color, scab, and body temperature increased are non-serious and 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 blister accompanied by pain, skin red, red spots and skin peeling off 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.The events of skin scarring and presented dark color, scab, and body temperature increased are non-serious and assessed as associated with the use of the device.This case meets follow up 10-day eu and 30-day fda reportability.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Case description: this is a spontaneous report from a contactable nurse.An (b)(6)-years-old female patient of an unspecified ethnicity received thermacare heatwrap (thermacare lower back & hip), lot h09901, expire date may2016), first use, via topical on (b)(6) 2016 at 1 dose single for pain.The heathwrap was applied by the reporting nurse, over a layer of clothing (cotton sweater).The nurse confirmed that the patient hadn't been lying over the heathwrap nor had made any pressure on the heatwrap.Medical history included ongoing diabetes insulin-dependent, cardiac disease, circulation problems and thyroid disease.The patient has no prior history of rheumatoid arthritis, neuropathy of allergic skin reactions.Concomitant medications included levothyroxine sodium (euthyrox) for thyroid disease, allopurinol (allopurinol), acetylsalicylic acid (tromalyt) for cardiac disease and insulin (insulin) for diabetes.On (b)(6) 2016, during application of thermacare heatwrap, the patient experienced burn with blisters on thermacare application site, accompanied by pain as well as body temperature increase (up to 39ºc).The patient initially experienced red spots on the thermacare application site, which evolved to blisters (some bursting) and skin peeling off.The heatwrap was applied only during 4,5h.The nurse verified periodically the patient's skin and body during the application, and noticed the body temperature increase (from 37ºc up to 39ºc) and the skin becoming red, so took off the heatwrap at the end of 4,5h of application.The patient was observed at the hospital emergency department as a result of the events.The patient was not hospitalized.At the hospital, on (b)(6) 2016, the patient underwent tests and procedures which included, chest x-ray and blood test, both normal.In the absence of other causes, the events were attributed to the thermacare heatwrap use.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Therapeutic measures were taken as a result of burn with blisters on thermacare application site accompanied by pain, and included topical application of physiological saline solution and trolamine (biafine).The patient was recovered from body temperature increase, the scabs from the burning wound fell off on (b)(6) 2016.The patient now presents scars with discoloration.The patient recovered with sequelae from burn with blisters on (b)(6) 2016 and recovered from skin peeling on an unspecified date.The patient is not recovered from scar and skin discoloration.The patient still experienced some pain on the area.The reporting nurse expects the patient to experience long-term sequelae such as scarring.Additional information has been requested and will be provided as it becomes available.Investigation summary included the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Follow-up (22apr2016): new information received from a contactable nurse included reaction data (additional event of scab and the outcome of events).Follow-up (20may2016): new information received from the product quality complaints group includes: quality investigation results.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the event burn blister accompanied by pain, skin red, red spots and skin peeling off 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.The events of skin scarring and presented dark color, scab, and body temperature increased are non-serious and assessed as associated with the use of the device.This case meets final (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the event burn blister accompanied by pain, skin red, red spots and skin peeling off 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.The events of skin scarring and presented dark color, scab, and body temperature increased are non-serious and assessed as associated with the use of the device.This case meets final (b)(6) and 30-day fda reportability.Continued: evaluation summary: the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical 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.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017 ; 2127334552
• MDR Report Key: 5599984
• MDR Text Key: 43514941
• Report Number: 1066015-2016-00068
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2016

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
• Device Expiration Date: 05/01/2016
• Device Lot Number: H09901
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/06/2016; 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR