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

PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

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Lot Number CK9820

Device Problems Overheating of Device (1437); Use of Device Problem (1670)

Patient Problem Burn, Thermal (2530)

Event Date 12/01/2019

Event Type Injury

Event Description

Burn [thermal burn].Probably didn't pay attention to the signs that it was getting too hot [device issue].Case narrative: this is a spontaneous report from a contactable other health care professional (hcp) received via a sales representative.An elderly male patient ' over 70 years old' started to receive thermacare heatwrap (thermacare lower back & hip) package of 4, device lot number ck 9820 expiration date jun2022, via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The action taken in response to the event for thermacare heatwrap was unknown.The 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 events thermal burn and device issue as described are considered serious bodily injury potentially 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.Comment: based on the information provided, the events thermal burn and device issue as described are considered serious bodily injury potentially 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.

Event Description

Event verbatim [preferred term] oozing burn blister [burns second degree] , probably didn't pay attention to the signs that it was getting too hot [device issue] , applied heat wrap directly to skin despite warning about increased burn risk for patients over 50 years/thermacare contact intensified by belt [device use error].Case narrative:this is a spontaneous report from a contactable health care professional (hcp) received via a sales representative.An elderly female patient "over 70 years old" started to receive thermacare heatwrap (thermacare lower back & hip) package of 4, device lot number ck9820, expiration date jun2022, from an unspecified date for an unspecified indication.Medical history and concomitant medications were not reported.The patient had used thermacare before, it was not her first heat wrap but so far she had not experienced any problems.The patient experienced a burn blister which occurred a few days before christmas ((b)(6) 2019).Unfortunately, the warnings were not noticed and subsequently the heat wrap was administered directly to the skin (warning regarding increased risk for burns in patients over 50 years).After a while the area hurt, however, patient did not associate this with a burn.The heat wrap was only removed later but by then an oozing burn blister had already developed.The patient developed burn with blistering in the back 2 cm x 1 cm, 2nd degree, slight erythema, oozing.The reporter stated the patient was over 70 years old and probably didn't pay attention to the signs that it was getting too hot.Moreover thermacare contact was intensified with belt.The event did not require surgical intervention or treatment, no risk factors were known, patient will not sustain lasting sequelae.It was unknown whether patient had used other medications including topical formulations at the time of the event.The action taken with thermacare heatwrap was unknown and the outcome of the event was unknown.Product quality complaints provided the following information: batch ck9820 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.The cause of the consumer reporting receiving a 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 when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "a burn." the cause of the consumer stating the wrap caused burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.Follow-up (14jan2020): new information received from the contactable consumer includes: demographic data (patient is female) and event information.Follow-up (21feb2020): new information from a contactable other healthcare professional includes description of the event, information that thermacare contact was intensified with belt, information about course and treatment of the event (no treatment).Follow-up (28feb2020): new information from product quality complaints includes: investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events thermal burn, device issue, and device use error as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Event Description

Event verbatim [preferred term].Oozing burn blister [burns second degree], probably didn't pay attention to the signs that it was getting too hot [device issue] , applied heat wrap directly to skin despite warning about increased burn risk for patients over 50 years/thermacare contact intensified by belt [device use error].Case narrative:this is a spontaneous report from a contactable health care professional (hcp) received via a sales representative and from a contactable pharmacist.An elderly female patient "over 70 years old" started to receive thermacare heatwrap (thermacare lower back & hip) package of 4, device lot number ck9820, expiration date jun2022, from an unspecified date for an unspecified indication.Medical history and concomitant medications were not reported.The patient had used thermacare before, it was not her first heat wrap but so far she had not experienced any problems.The patient experienced a burn blister which occurred a few days before christmas (b)(6) 2019.Unfortunately, the warnings were not noticed and subsequently the heat wrap was administered directly to the skin (warning regarding increased risk for burns in patients over 50 years).After a while the area hurt, however, patient did not associate this with a burn.The heat wrap was only removed later but by then an oozing burn blister had already developed.The patient developed burn with blistering in the back 2 cm x 1 cm, 2nd degree, slight erythema, oozing.The reporter stated the patient was over 70 years old and probably didn't pay attention to the signs that it was getting too hot.Moreover thermacare contact was intensified with belt.The event did not require surgical intervention or treatment, no risk factors were known, patient will not sustain lasting sequelae.It was unknown whether patient had used other medications including topical formulations at the time of the event.The action taken with thermacare heatwrap was unknown and the outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (14jan2020): new information received from the contactable consumer includes: demographic data (patient is female) and event information.Follow-up (21feb2020): new information from a contactable other healthcare professional includes description of the event, information that thermacare contact was intensified with belt, information about course and treatment of the event (no treatment).Comment: based on the information provided, the events thermal burn, device issue, and device use error as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.

Event Description

Event verbatim [preferred term], oozing burn blister [burns second degree], probably didn't pay attention to the signs that it was getting too hot [device issue], applied heat wrap directly to skin despite warning about increased burn risk for patients over 50 years/thermacare contact intensified by belt [device use error], , narrative: this is a spontaneous report from a contactable health care professional (hcp) received via a sales representative.An elderly female patient "over 70 years old" started to receive thermacare heatwrap (thermacare lower back & hip) package of 4, device lot number ck9820, expiration date jun2022, from an unspecified date for an unspecified indication.Medical history and concomitant medications were not reported.The patient had used thermacare before, it was not her first heat wrap but so far she had not experienced any problems.The patient experienced a burn blister which occurred a few days before christmas ((b)(6) 2019).Unfortunately, the warnings were not noticed and subsequently the heat wrap was administered directly to the skin (warning regarding increased risk for burns in patients over 50 years).After a while the area hurt, however, patient did not associate this with a burn.The heat wrap was only removed later but by then an oozing burn blister had already developed.The patient developed burn with blistering in the back 2 cm x 1 cm, 2nd degree, slight erythema, oozing.The reporter stated the patient was over 70 years old and probably didn't pay attention to the signs that it was getting too hot.Moreover thermacare contact was intensified with belt.The event did not require surgical intervention or treatment, no risk factors were known, patient will not sustain lasting sequelae.It was unknown whether patient had used other medications including topical formulations at the time of the event.The action taken with thermacare heatwrap was unknown and the outcome of the event was unknown.Product quality complaints provided the following information: batch ck9820 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.The cause of the consumer reporting receiving a 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 when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "a burn." the cause of the consumer stating the wrap caused burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.Product trend results dated 08oct2020 was as follows: lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.The previous complaint was not confirmed to have a manufacturing root cause related to the subclass.A visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assessment & rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) customizable search was performed.Scope: date contacted: 01/08/2017 through 01/08/2020/manufacturing site: pfizer albany/complaint class: external cause investigation complaint subclass: adverse event/severe/unknown.The citi customizable search returned a total of 110 complaints for lower back/hip 8hr 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.The data shows a spike of complaints received in may 2019; twenty of the 48 complaints received were related to burns, blisters, and redness; twenty-eight has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.S1-too cool, heat/cold did not last long enough, never worked.Complaints with 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 are investigated attaching memo (b)(4) effective 19-jun-2020.May 2019 shows an increase attributed 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 april 2019.According to (b)(4), hazard analysis, thermacare heat wrap product: 8 and 12hr, effective 30-apr-2020, section 10.1 - market actions (recall), effective date: 30-apr-2020, in april 2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower back, and hip include s97473 (us), s00639 (germany/switzerland), s23902 (uk/ireland), and w37940 (germany/switzerland).The recall action taken after the batches were released with an out of specification result for high-temperature cell(s), and no product isolation of impacted product performed.The release of these batches without product isolation is a compliance gap.The manufacturing investigation ((b)(4), closed 04-sep-2019) resulted in corrective actions, including improving procedures for containing and investigating the nonconforming.Follow-up (14jan2020): new information received from the contactable consumer includes: demographic data (patient is female) and event information.Follow-up (21feb2020): new information from a contactable other healthcare professional includes description of the event, information that thermacare contact was intensified with belt, information about course and treatment of the event (no treatment).Follow-up (28feb2020): new information from product quality complaints includes: investigation results.Follow-up (08oct2020): new information received from pfizer product quality group includes: investigation trend results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events thermal burn, device issue, and device use error as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the events cannot be ruled out.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.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

Batch ck9820 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.The cause of the consumer reporting receiving a 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 when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused "a burn." the cause of the consumer stating the wrap caused burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.Lot trend assessment & rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.The previous complaint was not confirmed to have a manufacturing root cause related to the subclass.Per sop-105746, complaint trending guideline, effective 19-nov-2019, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assessment & rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage and investigation (citi) customizable search was performed.Scope: date contacted: 01/08/2017 through 01/08/2020/manufacturing site: pfizer albany/complaint class: external cause investigation complaint subclass: adverse event/severe/unknown.The citi customizable search returned a total of 110 complaints for lower back/hip 8hr 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.The data shows a spike of complaints received in may 2019; twenty of the 48 complaints received were related to burns, blisters, and redness; twenty-eight has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.S1-too cool, heat/cold did not last long enough, never worked.Complaints with a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per (b)(4) hazard analysis, thermacare heat wrap product: 8 and 12hr are investigated attaching memo (b)(4) effective 19-jun-2020.May 2019 shows an increase attributed 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 april 2019.According to (b)(4), hazard analysis, thermacare heat wrap product: 8 and 12hr, effective 30-apr-2020, section 10.1 - market actions (recall), effective date: 30-apr-2020, in april 2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower back, and hip include s97473 (us), s00639 (germany/switzerland), s23902 (uk/ireland), and w37940 (germany/switzerland).The recall action taken after the batches were released with an out of specification result for high-temperature cell(s), and no product isolation of impacted product performed.The release of these batches without product isolation is a compliance gap.The manufacturing investigation ((b)(4), closed 04-sep-2019) resulted in corrective actions, including improving procedures for containing and investigating the nonconforming.

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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

MDR Report Key

9604001

MDR Text Key

188652544

Report Number

1066015-2020-00010

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

01/08/2020

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

06/01/2022

Device Lot Number

CK9820

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

01/17/2020

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided
Not provided

Supplement Dates FDA Received

02/04/2020
03/13/2020
03/26/2020
10/16/2020

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 LOWER BACK & HIP; DISPOSABLE PACK, HOT

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