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

Lot Number L31419

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Injury (2348); Partial thickness (Second Degree) Burn (2694)

Event Date 01/16/2016

Event Type  Injury  

Event Description

A 2nd degree burn of about 2 cm by 2 cm on the lower back [burns second degree] case description: this is a spontaneous report from a pfizer-sponsored marketing program, corporate website pfizer (b)(4).A contactable consumer reported a female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she experienced a 2nd degree burn of about 2 cm by 2 cm on the lower back.She stated she had to visit her physician.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the event 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 event "2nd degree burn" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is 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 "2nd degree burn" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

2nd degree burn of about 3 cm in diameter on the lower back [burns second degree], slept approximately 8 hours while using the heatwrap, did not check the condition of her skin under the product while wearing it [intentional device misuse].Case description: this is a spontaneous report from a (b)(6).A contactable consumer reported a (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: l31419, expiration date: jan2018) from (b)(6) 2016 for lumbar pain.The patient's medical history was not reported.The patient was not taking any concomitant medications.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date in (b)(6) 2014 for 4 days for an unspecified indication with no adverse effect.On (b)(6) 2016, on the second night of using the product, the patient reported she experienced a 2nd degree burn of about 3 cm by 3 cm in diameter on the lower back.She stated only the last compartment on the right side of the heatwrap caused the burn.As she took the wrap off, she noticed the burn.The patient contacted her physician as a result of the event.She mentioned she applied the heatwrap adhesive directly to the body and slept approximately 8 hours while using the heatwrap.The patient did not perform a sportive activity while using the heatwrap and did not check the condition of her skin under the product while wearing it.She reported she had read the instructions before using the product and used the heatwraps for 8 hours each time.No hospitalization or therapeutic measures were necessary.The patient assessed her skin tone as very light to light.She stated she had sensitive skin but no skin problems.The patient reported she was not currently under the treatment of a physician for any specific disease.She denied suffering from the following diseases: diabetes, circulation problems, cardiac disease, difficulty feeling heat or pain on the skin, rheumatoid polyarthritis, decreased sensitivity and nerve damage.The patient had previously used heating products (like electric heating cushions, hot water bottles or heating gel packs) in (b)(6) 2010 for approximately 5 days and experienced no problems.Action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6) 2016.Clinical outcome of the event was resolved on an unspecified date.Upon follow-up received on 01feb2016 from product complaint group, summary of investigation includes: 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.Additional information has been requested and will be provided as it becomes available.Follow-up (22jan2016): new information received from same contactable consumer via product complaint group includes: suspect product lot number and expiration date.Follow-up (01feb2016): new information received from product complaint group includes: summary of investigation.Follow-up (04feb2016): new information received from the same contactable consumer includes: patient details (age, height and weight), past product history, updated suspect product, suspect product start/stop dates, suspect product indication, action taken with the suspect product, event onset date, reaction data (additional event of device misuse), event outcome, no therapeutic measures were taken and no hospitalization was required.Company clinical evaluation comment based on the information provided, the event "2nd degree burn" and device misuse 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 event is assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event "2nd degree burn" and device misuse 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 event is assessed as associated with the use of the device.This case meets final10-day eu and 30-day fda reportability.

Manufacturer Narrative

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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.

Event Description

Case description: this is a spontaneous report from a pfizer-sponsored marketing program, corporate website pfizer (b)(4) (www.Pfizer.(b)(4)).A contactable consumer reported a female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwrap) (device lot number: l31419, expiration date: jan2018) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she experienced a 2nd degree burn of about 2 cm by 2 cm on the lower back.She stated she had to visit her physician.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the event was unknown.Upon follow-up received on 01feb2016 from product complaint group, summary of investigation includes: 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.Additional information has been requested and will be provided as it becomes available.Follow-up (22jan2016): new information received from same contactable consumer via product complaint group includes: suspect product lot number and expiration date.Follow-up (01feb2016): new information received from product complaint group includes: summary of investigation.Company clinical evaluation comment based on the information provided, the event "2nd degree burn" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event "2nd degree burn" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary 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.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.

Event Description

Case description: this is a spontaneous report from a pfizer-sponsored marketing program, corporate website pfizer (b)(4) (www.Pfizer.(b)(4)).A contactable consumer reported a female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwrap) (device lot number: l31419, expiration date: jan2018) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported she experienced a 2nd degree burn of about 2 cm by 2 cm on the lower back.She stated she had to visit her physician.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(6) 2016): new information received from same contactable consumer via product complaint group includes: suspect product lot number and expiration date.Company clinical evaluation comment based on the information provided, the event "2nd degree burn" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is 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 "2nd degree burn" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets follow-up 10-day eu and 30-day fda reportability.

• 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: 5393199
• MDR Text Key: 36912366
• Report Number: 1066015-2016-00015
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2016

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: 01/01/2018
• Device Lot Number: L31419
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 01/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/09/2016; 02/12/2016; 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 61