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

Lot Number J34848

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Two huge burns that had already burst [thermal burn].Had already burst [skin disorder].Got too hot [product quality issue].Scar [scar].Case description: this is a spontaneous report from (b)(6) sponsored program corporate website (b)(6).Received from a contactable consumer.A female patient of an unspecified age and ethnicity used thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.After two hours of use on the back thermacare heatwrap got too hot.The patient experienced two huge burns that had already burst.After 1 month the patient had still a scar.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the events e two huge burns that had already burst, the thermacare heatwrap got too hot was recovered on an unknown date, the outcome of the event scar was not recovered.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the events thermal burn, skin disorder, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn, skin disorder, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.This case meets initial 10-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.

Event Description

Case description: this is a spontaneous report from pfizer sponsored program corporate website pfizer (b)(4).Received from a contactable consumer.A female patient of an unspecified age and ethnicity used thermacare heatwrap (thermacare lower back & hip) (lot #: j34848, expiration date: sep2017) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.After two hours of use on the back, thermacare heatwrap got too hot.The patient experienced two huge burns that had already burst.After 1 month the patient still had a scar.Action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events, two huge burns that had already burst and thermacare heatwrap got too hot was resolved on an unknown date.The outcome of the event scar was not resolved.New information received from product quality complaint (pqc) group includes investigation results.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.Additional information has been requested and will be provided as it becomes available.Follow-up (30mar2016): new information from the same contactable consumer includes: product lot number and expiration date.Follow-up (05apr2016): 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 thermal burn, skin disorder, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.This case meets final (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn, skin disorder, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.This case meets final (b)(6) 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.

Event Description

Case description: this is a spontaneous report from pfizer sponsored program corporate website (b)(4).Received from a contactable consumer.A female patient of an unspecified age and ethnicity used thermacare heatwrap (thermacare lower back & hip, lot #j34848 and expiration date: 2017-09) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.After two hours of use on the back thermacare heatwrap got too hot.The patient experienced two huge burns that had already burst.After 1 month the patient still had a scar.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events, two huge burns that had already burst and the thermacare heatwrap got too hot was recovered on an unknown date.The outcome of the event scar was not recovered.Additional information has been requested and will be provided as it becomes available.Follow-up (30mar2016): new information from the same contactable consumer includes: product lot number and expiration date.Company clinical evaluation comment based on the information provided, the events thermal burn, skin disorder, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.This case meets follow-up10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn, skin disorder, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.This case meets follow-up 10-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.No trend has been identified for the subclass of too hot for lbh products.

Event Description

Two huge burns that had already burst [burns second degree], had already burst [blister rupture], got too hot [product quality issue], scar [scar].Case description: this is a spontaneous report from (b)(6) received from a contactable consumer.A female patient of an unspecified age and ethnicity used thermacare heatwrap (thermacare lower back & hip) (lot #: j34848, expiration date: sep2017) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.After two hours of use on the back, thermacare heatwrap got too hot.The patient experienced two huge burns that had already burst.After 1 month the patient still had a scar.Action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events, two huge burns that had already burst and thermacare heatwrap got too hot was resolved on an unknown date.The outcome of the event scar was not resolved.New information received from product quality complaint (pqc) group includes investigation results.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.No trend has been identified for the subclass of too hot for lbh products.Additional information has been requested and will be provided as it becomes available.Follow-up (30mar2016): new information from the same contactable consumer includes: product lot number and expiration date.Follow-up (05apr2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (13aug2016): new information received from product quality complaints (pqc) group included in investigation summary: add the expedited complaint trending paragraph in the initial complaint assessment, no trend has been identified for the subclass of too hot for lbh products.Updated llt for event terms 'two huge burns that had already burst' from llt burn to llt burn blister; and from llt skin disorder to llt burn rupture.Company clinical evaluation comment based on the information provided, the events two huge burns that had already burst, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events two huge burns that had already burst, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.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.No trend has been identified for the subclass of too hot for lbh products.

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.No trend has been identified for the subclass of too hot for lbh products.

Event Description

Event verbatim [preferred term].Huge burns on two sites that had already burst [burns second degree], had already burst [blister rupture], did not check her skin under the product while wearing the wrap [intentional device misuse], got too hot [device issue], scar [scar].Case narrative:this is a spontaneous report from (b)(6).A contactable consumer reported a (b)(6)-year-old female patient of an unspecified ethnicity used thermacare heatwrap (thermacare lower back & hip) (lot #: j34848, expiration date: sep2017) one time for 1 and 1/2 hours from an unspecified date for back pain.The patient's medical history included "an accident" on an unspecified date and unknown if ongoing (currently under the care of a physician) and atopic dermatitis from an unspecified date and unknown if ongoing.Concomitant medications were reported as none.The patient denied being pregnant.On an unspecified date, after 1 and 1/2 hours of use on the back, the patient reported the heatwrap got hotter and hotter and then she removed it.Consequently, the patient experienced huge burns on two sites that had already burst.She stated she attached the adhesive directly to the body, against the painful area (on the back).While using the product, the patient reported she did sport, reported as "riding" for 1 and 1/2 hours.She stated she did not check her skin under the product while wearing the wrap.After 1 month the patient still had an ugly scar.The patient denied consulting a healthcare professional as a result of the events.The patient assessed her skin tone as dark.She denied having sensitive skin.The patient reported she never used thermacare heatwraps before, but previously used other heat products for pain relief such as electric heating pad, hot water bottle or microwave gel pack for 1 week without experiencing problems/symptoms.She stated she read the usage instructions for the heatwrap before she used the product.The patient denied taking any medications during the time the problem/symptom was experienced.Action taken in response to the events for thermacare heatwrap was unknown.Clinical outcome of the events burn blister and blister rupture was resolved on an unspecified date.Clinical outcome of the event scar was not resolved.New information received from product quality complaint (pqc) group includes investigation results.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.No trend has been identified for the subclass of too hot for lbh products.Additional information has been requested and will be provided as it becomes available.Follow-up (30mar2016): new information from the same contactable consumer includes: product lot number and expiration date.Follow-up (05apr2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (13aug2016): new information received from product quality complaints (pqc) group included in investigation summary: add the expedited complaint trending paragraph in the initial complaint assessment, no trend has been identified for the subclass of too hot for lbh products.Updated llt for event terms 'two huge burns that had already burst' from llt burn to llt burn blister; and from llt skin disorder to llt blister rupture.Follow-up (06oct2016): new information received form the same contactable consumer includes: patient details, medical history, suspect product indication and reaction data (additional event of intentional device misuse).Company clinical evaluation comment based on the information provided, the events two huge burns that had already burst, intentional device misuse, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.No device malfunction has been identified., comment: based on the information provided, the events two huge burns that had already burst, intentional device misuse, and heat wrap got too hot 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 other event scar is assessed as associated with the device use.No device malfunction has been identified.

• 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
• 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: 5547765
• MDR Text Key: 41899778
• Report Number: 1066015-2016-00057
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/23/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2017
• Device Lot Number: J34848
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/07/2016; 04/26/2016; 09/08/2016; 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR