MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

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Lot Number X57707; W61097

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Rupture (2208); Partial thickness (Second Degree) Burn (2694)

Event Date 01/30/2019

Event Type Injury

Event Description

Event verbatim [preferred term] 4 blisters/burn/skin intact slightly pink/1 of which (blisters) had burst [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable other healthcare professional.A 14-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap) batch number unknown (identified 2 pfizer batch numbers in this case- x57707 exp jun 2021; w61097 exp jun 2020 awaiting confirmation) topically from 28jan2019 for non pharmacological pain relief.The reporter did not know which batch and wrap caused the burn as it had been disposed of.Relevant medical history included ongoing ehlers danlos syndrome.Concomitant medications were none.The patient was not taking any other relevant medications including topical medications at the time of the events.At 18:35 on 30jan2019, the heat pack was applied bilaterally to the patients shoulders.At 23:45, one of the heat packs was removed at the patient's request.The skin intact was slightly pink but the patient had no blisters at this time.At 06:00 the nurse noticed that the patient's t shirt was wet and had a look at the area.The patient had 4 burn/blisters (which were the same size as the padding marks on the heat pack), 1 of which (blisters) had burst.Start date for all events was reported as 30jan2019.First aid was applied, the medics were informed, the patient's wounds were cleaned and jelonet was applied.Both the tissue viability and medical consultant reviewed the patient.No surgical intervention such as debridement was required.Action taken with thermacare heatwrap was to permanently withdraw treatment on 30jan2019.It was reported that the heat pack had been on for 5 hours10mins and that the patient had previously use thermacare heatwrap with no issues.The outcome of the events were not recovered at the time of this follow up report.It was unknown whether the patient was expected to experienced long term sequelae such as scarring.The reporter considered the events to be serious (medically significant).The healthcare professional thought that there was a reasonable possibility that the event was related to thermacare heatwrap.He reported that the 'heat pack on other side had no issues'.According to product quality complaint group: initial complaint assessment: batch x57707/w61097 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 01-apr-2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: 03/28/2017 through 03/28/2019/manufacturing site: pfizer albany/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 140 complaints for neck shoulder wrist (nsw) products during this time period for the class/subclass.Of the 140 complaints; 33 complaints have batch number recorded as "unknown".The 107 remaining complaints were evaluated.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for nsw products, see attached trending graph 2019-03-0021205-ik.The adverse events complaint subclass show an increase in november 2018 thru february 2019.This is a seasonality change in combination with a change in safety's procedure wsr-cp001-wi 110, "case processing principles product quality complaint guidance", updated on august 20, 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6c to 41.9c) per spec-34820; effective date: (b)(6) 2018.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Investigation summary: the root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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 (21mar2019): new information received from the same contactable healthcare professional included: patient data (age, gender), suspect product data (start date, stop date, route, indication, action taken), medical history, deny of concomitant medication, past drug history, new events (4 blisters/burn/skin intact slightly pink, 1 of which (blisters) had burst), treatment received and case upgraded to serious, reportable mdr.Follow-up (02apr2019): new information received from product quality complaint group included: investigation results.Follow-up (23apr2019): new information received from product quality complaint group included: investigation results regarding another lot number w61097., comment: based on the information provided, the event of "burn blisters" as described is considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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.

Manufacturer Narrative

Batch x57707/w61097 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on 01-apr-2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: 03/28/2017 through 03/28/2019/manufacturing site: pfizer albany/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 140 complaints for neck shoulder wrist (nsw) products during this time period for the class/subclass.Of the 140 complaints; 33 complaints have batch number recorded as "unknown".The 107 remaining complaints were evaluated.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for nsw products, see attached trending graph 2019-03-0021205-ik.The adverse events complaint subclass show an increase in november 2018 thru february 2019.This is a seasonality change in combination with a change in safety's procedure wsr-cp001-wi 110, "case processing principles product quality complaint guidance", updated on august 20, 2018 that has incorporated requesting site investigations for complaints with or without b.

Manufacturer Narrative

Batch x57707 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The pcom search returned a total of 140 complaints for neck shoulder wrist (nsw) products during this time period for the class/subclass.Of the 140 complaints; 33 complaints have batch number recorded as unknown.The 107 remaining complaints were evaluated.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for nsw products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6c to 41.9c) per spec-34820; effective date: (b)(6) 2018.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this.

Event Description

Event verbatim [preferred term] 4 blisters/burn/skin intact slightly pink [burns second degree], 1 of which (blisters) had burst [blister rupture].Case narrative:this is a spontaneous report from a contactable other healthcare professional.A 14-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap) batch number unknown (identified 2 pfizer batch numbers in this case- (b)(4), exp jun 2021; w61097, exp jun 2020 awaiting confirmation) topically from (b)(6) 2019 for non pharmacological pain relief.The reporter did not know which batch and wrap caused the burn as it had been disposed of.Relevant medical history included ongoing ehlers danlos syndrome.Concomitant medications were none.The patient was not taking any other relevant medications including topical medications at the time of the events.At 18:35 on (b)(6) 2019, the heat pack was applied bilaterally to the patients shoulders.At 23:45, one of the heat packs was removed at the patient's request.The skin intact was slightly pink but the patient had no blisters at this time.At 06:00 the nurse noticed that the patient's t shirt was wet and had a look at the area.The patient had 4 burn/blisters (which were the same size as the padding marks on the heat pack), 1 of which (blisters) had burst.Start date for all events was reported as (b)(6) 2019.First aid was applied, the medics were informed, the patient's wounds were cleaned and jelonet was applied.Both the tissue viability and medical consultant reviewed the patient.No surgical intervention such as debridement was required.Action taken with thermacare heatwrap was to permanently withdraw treatment on (b)(6) 2019.It was reported that the heat pack had been on for 5 hours and that the patient had previously use thermacare heatwrap with no issues.The outcome of the events were not recovered at the time of this follow up report.It was unknown whether the patient was expected to experienced long term sequelae such as scarring.The reporter considered the events to be serious (medically significant).The healthcare professional thought that there was a reasonable possibility that the event was related to thermacare heatwrap.He reported that the 'heat pack on other side had no issues'.According to product quality complaint group: batch x57707 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the three pouched wraps inside and shows no obvious defects.Retain sample inspection form documented the retain evaluation performed on (b)(6) 2019.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The pcom search returned a total of 140 complaints for neck shoulder wrist (nsw) products during this time period for the class/subclass.Of the 140 complaints; 33 complaints have batch number recorded as unknown.The 107 remaining complaints were evaluated.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for nsw products.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6c to 41.9c).There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Investigation summary: the root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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 (21mar2019): new information received from the same contactable healthcare professional included: patient data (age, gender), suspect product data (start date, stop date, route, indication, action taken), medical history, deny of concomitant medication, past drug history, new events (4 blisters/burn/skin intact slightly pink, 1 of which (blisters) had burst), treatment received and case upgraded to serious, reportable mdr.Follow-up (02apr2019): new information received from product quality complaint group included: investigation results., comment: based on the information provided, the events of "burn blisters" and "blister rupture" 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.

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Brand Name

THERMACARE HEATWRAP

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

8452641

MDR Text Key

139960806

Report Number

1066015-2019-00075

Device Sequence Number

Product Code

IMD

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

foreign,health professional

Type of Report

Initial,Followup,Followup

Report Date

02/01/2019

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?

Device Operator

Lay User/Patient

Device Expiration Date

06/01/2020

Device Lot Number

X57707; W61097

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

03/26/2019

Supplement Dates Manufacturer Received

Not provided
Not provided

Supplement Dates FDA Received

04/10/2019
04/26/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

14 YR

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

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