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

PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 05/24/2019

Event Type Injury

Event Description

2nd degree burns near his spine [burns second degree].Case narrative: this is a spontaneous report from a contactable physician reported for himself.This report was received via a company representative.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient sustained 2nd degree burns near his spine from thermacare.He was aghast that this can happen since he was scheduled for surgery and had to cancel the appointment because he developed the burn at the surgical area in question.The action taken in response to the event for thermacare heatwrap was unknown.The 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 of "2nd degree burns" as described is considered serious bodily injury potentially 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.

Event Description

Event verbatim [preferred term] 2nd degree burns near his spine [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable physician reporting for himself.This report was received via a company representative.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), from an unspecified date at unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient previously used thermacare and never had problems.The patient sustained 2nd degree burns near his spine from thermacare.He was aghast that this can happen since he was scheduled for surgery and had to cancel the appointment because he developed the burn at the surgical area in question.The reporting physician stated to be really appalled that after 5.5 hours such a severe burning occurred that he could not go to the physiotherapy for days.The whole issue was "super annoying." he excluded a user mistake.It was at least the 40th thermacare he had used, and as a doctor, he knew how to use it.So far, he never had problems.Unfortunately, he cannot provide the batch number.The outer packaging, he had thrown into the garbage and this was unfortunately already picked up.But the plaster, which was the cause of the burn, he still had with him.Unfortunately, the batch number was not reprinted on the plaster itself.Incidentally, the burning was only on one side and nothing on the other.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (31may2019): new information received from the same contactable physician includes: additional event clinical course.Company clinical evaluation comment based on the information provided, the event of "2nd degree burns" as described is considered serious bodily injury potentially 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., comment: based on the information provided, the event of "2nd degree burns" as described is considered serious bodily injury potentially 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.

Event Description

Manufacturer Narrative

Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.The 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.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage, and investigation (citi): customizable search was performed:scope: site notification date: (b)(6) 2016 through (b)(6) 2019 manufacturing site: (b)(4)./complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 704 complaints for lbh products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in (b)(6) 2018 thru (b)(6) 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 (b)(6) 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in (b)(6) 2019.Complaints increased due to consumers reporting adverse even.

Event Description

Event verbatim [preferred term] 2nd degree burns near his spine/severe pain/severe inflammation of the skin in the right lumbar area outside/skin scar [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable physician reporting for himself.This report was received via a company representative.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap), from (b)(6) 2019 at unknown frequency for lumbar spine problems.The patient medical history and concomitant medications were not reported.The patient previously used thermacare heatwrap for unknown indication and never had problems.The patient sustained 2nd degree burns near his spine from thermacare.He was aghast that this can happen since he was scheduled for surgery and had to cancel the appointment because he developed the burn at the surgical area in question.On (b)(6) 2019, he used the third part of a pack of thermacare heatwraps due to lumbar spine problems.After 6 hours of use he removed the heatwrap because of severe pain and had to notice a severe inflammation of the skin in the right lumbar area outside.The attached picture showed you the 2nd degree burn after thermacare use in a size of about 3 x 2 cm, which required a long-term local treatment.An unsightly skin scar in the appropriate size remained.The whole issue was "super annoying." he excluded a user mistake.It was at least the 40th thermacare he had used, and as a doctor, he knew how to use it.So far, he never had problems.For several years he had been using thermacare with good success with unchanged general medication.Unfortunately, he cannot provide the batch number.The outer packaging, he had thrown into the garbage and this was unfortunately already picked up.But the plaster, which was the cause of the burn, he still had with him.Unfortunately, the batch number was not reprinted on the plaster itself.Incidentally, the burning was only on one side and nothing on the other.The patient further admitted that he had not been aware of the additional warning regarding the burning risk for patients over 55 years.He did not know that administration over a thin piece of clothing was recommended for that patient group.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was resolved with sequel in 2019.Upon follow-up, product quality complaint reported that severity of harm was selected by the manufacturing site as s3 (injury, which could result in the need for medical treatment and hospitalization).Additional information received from product quality complaints included: rsnbly suggest device malfunc?: no.Severity of harm: n/a.Conclusion:the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.The 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.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage, and investigation (citi): customizable search was performed:scope: site notification date: (b)(6) 2016 through (b)(6) 2019/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 704 complaints for lbh products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in (b)(6) 2018 thru (b)(6) 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 (b)(6) 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in (b)(6) 2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from (b)(6) 2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and (b)(6) 2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.This is also observed in a review of the 24 month trend chart for this subclass.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.Based on this citi customizable search for the subclasses of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh product, refer to attachment unknown lbh adverse event (b)(6) 2016 to (b)(6) 2019.Exped trend actions taken:based on this citi customizable search for the subclasses of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh product, refer to attachment unknown lbh adverse event (b)(6) 2016 to (b)(6) 2019.Follow-up (b)(6) 2019): new information received from the same contactable physician includes: additional event clinical course.Follow-up (b)(6) 2019: new information from contactable physician included: suspect product data (start date, indication, device age), additional event details, event onset date, treatment received, event outcome.Follow-up (b)(6) 2019: new information received from the contactable physician includes additional event clinical course.No follow-up attempts are possible.No further information is expected.Follow-up (b)(6) 2019: new information received from product quality complaints includes: severity of harm (s3).Follow-up (b)(6) 2019: new information received from product quality complaint group includes investigation results.No follow-up attempts are possible.No further information is expected., comment: based on the information provided, the event of burns second degree 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.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.The root cause category is non-assignable (complaint not confirmed as a quality defect).Product effect varies with each individual.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

8658200

MDR Text Key

146658501

Report Number

1066015-2019-00175

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

company representative,foreig

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

05/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

05/31/2019

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Lay User/Patient

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

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

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