MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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Lot Number AJ3018

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

Patient Problems Itching Sensation (1943); Pain (1994); Skin Inflammation (2443); Burn, Thermal (2530)

Event Date 08/31/2020

Event Type Injury

Event Description

Itching/a blister in the size of a 5 cent coin that has already opened/reddened and painful/burn blisters [burns second degree].Narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number aj3018, expiration date 31oct2021, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient previously received tetanus vaccine and was vaccinated against tetanus.On the (b)(6) 2020 the patient put the patch on the left area between shoulder and neck area and removed the patch between 12 noon and 2 pm because it started itching underneath.The patient had a blister in the size of a 5 cent coin that had already opened and was being treated with betaisodona (povidone-iodine ointment or solution), it was still reddened and painful.The patient had used thermacare several times and had not had any complaints or burn blisters so far.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.

Manufacturer Narrative

Event Description

Event verbatim [preferred term], itching/a blister in the size of a 5 cent coin that has already opened/reddened and painful/burn blisters [burns second degree], narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number aj3018, expiration date oct2021 from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient previously received tetanus vaccine and was vaccinated against tetanus.On (b)(6) 2020, the patient put the patch on the left area between shoulder and neck and removed the patch between 12 noon and 2 pm because it started itching underneath.The patient had a blister in the size of a 5 cent coin that had already opened and was being treated with betaisodona (povidone-iodine ointment or solution), it was still reddened and painful.The patient had used thermacare several times and had not had any complaints or burn blisters so far.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Product quality complaints provided the following investigation information: batch aj3018 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.After a review of the batch thermal records the root cause category is non assignable and complaint can not be confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reported he had a blister size of a 5 cent coin.The cause of the consumer burns is inconclusive since review of the records does not provide evidence to support defective product.The effect of the product 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, thermal 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 (14sep2020): follow-up attempts completed.No further information expected.Follow-up (11sep2020): new information from pfizer product quality group includes investigation results.

Manufacturer Narrative

Event Description

Event verbatim [preferred term] itching/a blister in the size of a 5 cent coin that has already opened/reddened and painful/burn blisters [burns second degree], , narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number aj3018, expiration date oct2021 from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient previously received tetanus vaccine and was vaccinated against tetanus.On (b)(6) 2020, the patient put the patch on the left area between shoulder and neck and removed the patch between 12 noon and 2 pm because it started itching underneath.The patient had a blister in the size of a 5 cent coin that had already opened and was being treated with betaisodona (povidone-iodine ointment or solution), it was still reddened and painful.The patient had used thermacare several times and had not had any complaints or burn blisters so far.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was unknown.Product quality complaints provided the following investigation information for complaint sub class adverse event safety request for investigation: batch aj3018 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.Conclusion: after a review of the batch thermal records the root cause category is non assignable and complaint can not be confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reported he had a blister size of a 5 cent coin.The cause of the consumer burns is inconclusive since review of the records does not provide evidence to support defective product.The effect of the product 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, thermal 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 and rationale: 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.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.There is not a trend identified for the subclass adverse event safety request for investigation for nsw 12hr products.Refer to the 36-month trend chart attachment for adverse event safety request for investigation nsw 12hr 04 september 2017 through 04 september 2020.There is no further action required.Additional investigational results from the product quality complaint for complaint sub class adverse event serious unknown includes: batch aj3018 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.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, " he had a blister size of a 5 cent coin." the cause of the consumer stating the wrap caused a blister is inconclusive since review of records does not provide evidence to support defective product.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event serious unknown 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.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.There is not a trend identified for the subclass adverse event/serious/unknown for nsw 12hr products.Refer to the 36-month trend chart attachment for adverse event/serious/unknown nsw 12hr 04- september - 2017 through 04 -september - 2020.There is no further action required.Site sample status was not received.Follow-up (14sep2020): follow-up attempts completed.No further information expected.Follow-up (11sep2020): new information from pfizer product quality group includes investigation results.Amendment: this follow-up report is being submitted to amend previously reported information: historical vaccine updated to past drug event.Follow-up (23oct2020): new information received from the product quality complaint group includes investigational results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

Batch aj3018 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.Conclusion: after a review of the batch thermal records the root cause category is non assignable and complaint can not be confirmed as a quality defect.The batch thermal results met all product release criteria.The consumer reported he had a blister size of a 5 cent coin.The cause of the consumer burns is inconclusive since review of the records does not provide evidence to support defective product.The effect of the product 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, thermal 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 and rationale: 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.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.There is not a trend identified for the subclass adverse event safety request for investigation for nsw 12hr products.Refer to the 36-month trend chart attachment for adverse event safety request for investigation nsw 12hr 04 september 2017 through 04 september 2020.There is no further action required.Complaint sub class adverse event serious unknown includes: batch aj3018 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.Conclusion: the root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, " he had a blister size of a 5 cent coin." the cause of the consumer stating the wrap caused a blister is inconclusive since review of records does not provide evidence to support defective product.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.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event serious unknown 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.Expedite trend assessment and rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.There is not a trend identified for the subclass adverse event/serious/unknown for nsw 12hr products.Refer to the 36-month trend chart attachment for adverse event/serious/unknown nsw 12hr 04- september - 2017 through 04 -september - 2020.There is no further action required.Site sample status was not received.

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Brand Name

THERMACARE NECK, SHOULDER & WRIST

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

10515805

MDR Text Key

206371211

Report Number

1066015-2020-00161

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

consumer,foreign

Type of Report

Initial,Followup,Followup,Followup

Report Date

09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

09/10/2020

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Lay User/Patient

Device Expiration Date

10/01/2021

Device Lot Number

AJ3018

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 NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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