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 EC2269

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033)

Event Date 01/01/2020

Event Type Injury

Event Description

Event verbatim [preferred term] rash on her skin/it got worse throughout the day, expanding through the body and face [rash], she used it and it caused an allergic reaction.[hypersensitivity], inflammation caused by the allergic reaction [inflammation], narrative: this is a spontaneous report from a contactable consumer reporting for herself.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number ec2269, expiration date 30jun2023, upc number: (b)(4), topical from (b)(6) 2020 at one wrap applied to skin once for spasm in shoulder.There were no medical history and concomitant medications.The patient stated she bought thermacare neck, shoulder, and wrist, and the box didn't have the ingredients, or the pouch, and she used it on (b)(6) 2020 and it caused an allergic reaction.She only had it for one hour, and realized there was a rash on her skin.It got worse throughout the day, expanding through the body and face.She was still taking medication to decrease the inflammation caused by the allergic reaction.The first treatment she was put on didn't work, and was on another for 5 days, and it was unknown if after 5 days, she will need additional treatment.On monday she first took benadryl, then on tuesday she went to the doctor and took kenalog expiry is 20jun2022, lot is ap200162 and it didn't work.Then the doctor prescribed medrol, a 5 day treatment.Provided the name of the doctor, she didn't have a primary care, the doctor was the one who wrote the prescription.Provides us patent # and also had photos, photos of her skin.It was just one time because she only used one, there are three, she has the other two there.She has the box and also two pouches left.She has stopped using it, she was only with it for an hour and took it off.She will definitely stop using it, she was dealing with the consequences of the rash, and was in treatment to reduce the intensity of the rash caused by this, and she lost two days of work.The box was sealed and she has the other two and the box, and no where in the box or the pouches are the ingredients listed.She read on the internet about if this had recalls, she got scared of the rash this caused her, and some patents they do have recalls.Wanted to verify ingredients of the pad, since it was not listed? the product was available to be sent to pfizer for evaluation as she had two pouches she didn't use, the one she used has been thrown away.The reporter stated there is a reasonable possibility that the events rash, allergic reaction are related to the device/device constituent of a combination product because after she put it on, the rash started appearing.The action taken for the product was permanently discontinued on (b)(6) 2020.The events outcome was unknown.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Summary of investigation: batch #: ec2269; brand code/sku#: f00573301502x ; product count: 3 count; date of manufacture: 07jul2020 to 15jul2020; expiry date: 30jun2023; quantity released: 441,216 cartons.Batch ec2269 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch records, results all met product release criteria.Consumer reports the box doesn't have the ingredients, or the pouch, and she used it and it caused an allergic reaction.Is inconclusive since review of records does not provide evidence to support defective product.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 assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.A visual examination was performed to identify any potential trends for the subclass and lot number.Refer to the attached trend chart adverse event/negligible-minor lot# ec2269 nsw8.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.For complaint sub-class: adverse event/serious/unknown: conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch records, results all met product release criteria.Consumer reports "the box doesn't have the ingredients, or the pouch, and she used it and it caused an allergic reaction." is inconclusive since review of records does not provide evidence to support defective product.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 assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) site requiring an evaluation for this lot.A visual examination was performed to identify any potential trends for the subclass and lot number.Refer to the attached trend chart adverse event/negligible-minor lot# ec2269 nsw8.On the basis of this evaluation, a trend does not exist for this batch.

Event Description

Event verbatim [preferred term].She used it and it caused an allergic reaction/allergic reaction to thermacare neck wraps [hypersensitivity], rash on her skin/it got worse throughout the day, expanding through the body and face [rash].Itching [pruritus], broke out in hives all over her body [urticaria], inflammation caused by the allergic reaction [inflammation], narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 44-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number ec2269, expiration date 30jun2023, upc number: 305733015025, topical from (b)(6) 2020 at one wrap applied to skin once for spasm in shoulder.There were no medical history and concomitant medications.The patient stated she bought thermacare neck, shoulder, and wrist, and the box didn't have the ingredients, or the pouch, and she used it on (b)(6) 2020 and it caused an allergic reaction.She only had it for one hour, and realized there was a rash on her skin.It got worse throughout the day, expanding through the body and face.She was still taking medication to decrease the inflammation caused by the allergic reaction.The first treatment she was put on didn't work, and was on another for 5 days, and it was unknown if after 5 days, she will need additional treatment.On monday she first took benadryl, then on tuesday she went to the doctor and took kenalog expiry is 20jun2022, lot is ap200162 and it didn't work.Then the doctor prescribed medrol, a 5 day treatment.Provided the name of the doctor, she didn't have a primary care, the doctor was the one who wrote the prescription.Provides us patent # and also had photos, photos of her skin.It was just one time because she only used one, there are three, she has the other two there.She has the box and also two pouches left.She has stopped using it, she was only with it for an hour and took it off.She will definitely stop using it, she was dealing with the consequences of the rash, and was in treatment to reduce the intensity of the rash caused by this, and she lost two days of work.The box was sealed and she has the other two and the box, and no where in the box or the pouches are the ingredients listed.She read on the internet about if this had recalls, she got scared of the rash this caused her, and some patents they do have recalls.Wanted to verify ingredients of the pad, since it was not listed.The product was available to be sent to pfizer for evaluation as she had two pouches she didn't use, the one she used has been thrown away.The reporter stated there is a reasonable possibility that the events rash, allergic reaction are related to the device constituent of a combination product because after she put it on, the rash started appearing.It was further reported patient reported to fda complaints department that she had an allergic reaction to thermacare neck wraps after wearing the wrap for only one hour.She broke out in hives all over her body.The hives and itching in 2020 lasted for over a week.The patient also made a complaint as well, that there was not an ingredient list on the thermacare label.The patient stated she has a pfizer alias name of (b)(4) who makes thermacare products.She wanted to confirm the name of the company that makes thermacare, and the physical address.The patient wanted this answer emailed to her, and a list of the ingredients as well.The action taken for the product was permanently discontinued on (b)(6) 2020.The outcome of the events was unknown.According to the product quality complaint group: summary of investigation: batch #: ec2269; brand code/sku#: f00573301502x ; product count: 3 count; date of manufacture: 07jul2020 to 15jul2020; expiry date: 30jun2023; quantity released: 441,216 cartons.Batch ec2269 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch records, results all met product release criteria.Consumer reports the box doesn't have the ingredients, or the pouch, and she used it and it caused an allergic reaction.Is inconclusive since review of records does not provide evidence to support defective product.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 assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.A visual examination was performed to identify any potential trends for the subclass and lot number.Refer to the attached trend chart adverse event/negligible-minor lot# ec2269 nsw8.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.According to the product quality complaint group for complaint sub-class: adverse event/serious/unknown: conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch records, results all met product release criteria.Consumer reports "the box doesn't have the ingredients, or the pouch, and she used it and it caused an allergic reaction." is inconclusive since review of records does not provide evidence to support defective product.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 assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/serious/unknown received at the (site name) site requiring an evaluation for this lot.A visual examination was performed to identify any potential trends for the subclass and lot number.Refer to the attached trend chart adverse event/negligible-minor lot# ec2269 nsw8.On the basis of this evaluation, a trend does not exist for this batch.Follow-up (05oct2020): follow-up attempts completed.No further information expected.Follow-up (29oct2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.Follow-up (09nov2020): this is a follow-up report combining information from duplicate reports 2020431420 and 2020372794.The current and all subsequent information will be reported under manufacturer report number 2020372794.New information reported includes new events "broke out in hives all over her body" and "itching" added.Additional information received on (b)(6) 2020 from the product quality complaint group included investigational results for complaint sub-class: adverse event/serious/unknown.

Manufacturer Narrative

Event Description

Event verbatim [preferred term].Rash on her skin/it got worse throughout the day, expanding through the body and face [rash], she used it and it caused an allergic reaction.[hypersensitivity], inflammation caused by the allergic reaction [inflammation], , narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 44-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number ec2269, expiration date 30jun2023, upc number: 305733015025, topical from 21sep2020 to 21sep2020 at one wrap applied to skin once for spasm in shoulder.There were no medical history and concomitant medications.The patient stated she bought thermacare neck, shoulder, and wrist, and the box didn't have the ingredients, or the pouch, and she used it on (b)(6) 2020 and it caused an allergic reaction.She only had it for one hour, and realized there was a rash on her skin.It got worse throughout the day, expanding through the body and face.She was still taking medication to decrease the inflammation caused by the allergic reaction.The first treatment she was put on didn't work, and was on another for 5 days, and it was unknown if after 5 days, she will need additional treatment.On monday she first took benadryl, then on tuesday she went to the doctor and took kenalog expiry is (b)(6) 2022, lot is ap200162 and it didn't work.Then the doctor prescribed medrol, a 5 day treatment.Provided the name of the doctor, she didn't have a primary care, the doctor was the one who wrote the prescription.Provides us patent # and also had photos, photos of her skin.It was just one time because she only used one, there are three, she has the other two there.She has the box and also two pouches left.She has stopped using it, she was only with it for an hour and took it off.She will definitely stop using it, she was dealing with the consequences of the rash, and was in treatment to reduce the intensity of the rash caused by this, and she lost two days of work.The box was sealed and she has the other two and the box, and no where in the box or the pouches are the ingredients listed.She read on the internet about if this had recalls, she got scared of the rash this caused her, and some patents they do have recalls.Wanted to verify ingredients of the pad, since it was not listed? the product was available to be sent to pfizer for evaluation as she had two pouches she didn't use, the one she used has been thrown away.The reporter stated there is a reasonable possibility that the events rash, allergic reaction are related to the device/device constituent of a combination product because after she put it on, the rash started appearing.The action taken for the product was permanently discontinued on (b)(6) 2020.The events outcome was unknown.According to the product quality complaint group: summary of investigation: batch #: ec2269; brand code/sku#: f00573301502x ; product count: 3 count; date of manufacture: 07jul2020 to 15jul2020; expiry date: 30jun2023; quantity released: (b)(4)cartons.Batch ec2269 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve sample, and trending were evaluated no quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch records, results all met product release criteria.Consumer reports the box doesn't have the ingredients, or the pouch, and she used it and it caused an allergic reaction.Is inconclusive since review of records does not provide evidence to support defective product.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 assmt.& rationale: an evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event/negligible-minor received at the (site name) site requiring an evaluation for this lot.A visual examination was performed to identify any potential trends for the subclass and lot number.Refer to the attached trend chart adverse event/negligible-minor lot# ec2269 nsw8.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.Follow-up (05oct2020): follow-up attempts completed.No further information expected.Follow-up (29oct2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected.

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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

10619449

MDR Text Key

214753241

Report Number

1066015-2020-00171

Device Sequence Number

Product Code

IMD

UDI-Device Identifier

00305733015025

UDI-Public

305733015025

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

Report Date

09/25/2020

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

06/30/2023

Device Lot Number

EC2269

Was Device Available for Evaluation?

Yes

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

10/02/2020

Supplement Dates Manufacturer Received

Not provided
Not provided

Supplement Dates FDA Received

11/03/2020
11/17/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

44 YR

Patient Weight

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

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