MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MUSCLE & JOINT; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE MUSCLE & JOINT; DISPOSABLE PACK, HOT

Lot Number AA2377

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Burning Sensation (2146)

Event Type Injury

Event Description

States that where it was laying at that it is burning like [burning sensation] , stinging in the leg [pain in extremity] , twitching of the nerves [muscle twitching] , he put a pfizer heat pack on and forgot and went to sleep in it [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).An (b)(6) year-old male patient started to receive thermacare heatwrap (thermacare heatwrap) from an unspecified date for an unspecified indication.Device lot number and expiration date were not available.Medical history included ongoing diabetes from an unknown date.The patient's concomitant medications were not reported.The consumer reported that he put a pfizer heat pack on and forgot and went to sleep in it on an unspecified date.Thermacare heat wrap went around waist and leg.About 4 days after that he got stinging in the leg and twitching of the nerves.He reported that where it was laying at that it was burning like.The action taken in response to the event for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the events burning sensation, pain in extremity, muscle twitching and device use error as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] states that where it was laying at that it is burning like [burning sensation] , stinging in the leg/he had a sting in the leg [pain in extremity] , twitching of the nerves [muscle twitching] , he put a pfizer heat pack on and forgot and went to sleep in it/ kept the wrap on overnight [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).An 87-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) device lot number: a2377 and expiration date: nov2021, from an unspecified date for an unspecified indication.Medical history included ongoing diabetes from an unknown date.The patient's concomitant medications were not reported.The consumer reported that that he put a pfizer heat pack on and forgot and went to sleep in it/ kept the wrap on overnight on an unspecified date.Thermacare heat wrap went around waist and leg.About 4 days after that he got stinging in the leg and twitching of the nerves.He reported that where it was laying at that it was burning like.He further reported that after using the product for 4 days; he had a sting in the leg.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (17mar2020): new information received from a contactable consumer includes: product trade name, lot number, expiry date, more events detail., comment: based on the information provided, the events burning sensation, pain in extremity, muscle twitching and device use error as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

Summary of investigation: batch aa2377 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 reports after falling asleep with the wrap adhered to his leg, he experienced a "sting" in his leg hours later.The cause of the consumer stating he experienced a sting 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 risk of skin irritation.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 second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.The sample had not been received by the site.

Event Description

Event verbatim [preferred term].States that where it was laying at that it is burning like [burning sensation], stinging in the leg/he had a sting in the leg [pain in extremity], twitching of the nerves [muscle twitching], he put a pfizer heat pack on and forgot and went to sleep in it/ kept the wrap on overnight [device use error].Narrative: this is a spontaneous report from a contactable consumer (patient).An 87-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) device lot number: aa2377 and expiration date: nov2021, from an unspecified date for an unspecified indication.Medical history included ongoing diabetes from an unknown date.The patient's concomitant medications were not reported.The consumer reported that he put a pfizer heat pack on and forgot and went to sleep in it/ kept the wrap on overnight on an unspecified date.Thermacare heat wrap went around waist and leg.About 4 days after that he got stinging in the leg and twitching of the nerves.He reported that where it was laying at that it was burning like.He further reported that after using the product for 4 days; he had a sting in the leg.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to product quality complaint group: summary of investigation: batch aa2377 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 reports after falling asleep with the wrap adhered to his leg, he experienced a "sting" in his leg hours later.The cause of the consumer stating he experienced a sting 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 risk of skin irritation.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 second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.The sample had not been received by the site.Severity of harm was s3.Follow-up (17mar2020): new information received from a contactable consumer includes: product trade name, lot number, expiry date, more events detail.Follow-up (20apr2020): new information received from a product complaint group included: investigation results and severity of harm.Comment: based on the information provided, the events burning sensation, pain in extremity, muscle twitching and device use error 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.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] he put a pfizer heat pack on and forgot and went to sleep in it/ kept the wrap on overnight [device use error], states that where it was laying at that it is burning like [burning sensation], stinging in the leg/he had a sting in the leg [pain in extremity], twitching of the nerves [muscle twitching].Narrative: this is a spontaneous report from a contactable consumer (patient).An 87-year-old male patient started to receive thermacare heatwrap (thermacare muscle & joint), device lot number: aa2377 and expiration date: nov2021, from an unspecified date for an unspecified indication.Medical history included ongoing diabetes from an unknown date.The patient's concomitant medications were not reported.The consumer reported that he put a pfizer heat pack on and forgot and went to sleep in it/ kept the wrap on overnight on an unspecified date.Thermacare heat wrap went around waist and leg.About 4 days after that he got stinging in the leg and twitching of the nerves.He reported that where it was laying at that it was burning like.He further reported that after using the product for 4 days; he had a sting in the leg.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to product quality complaint group: summary of investigation: batch aa2377 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 reports after falling asleep with the wrap adhered to his leg, he experienced a "sting" in his leg hours later.The cause of the consumer stating he experienced a sting 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 risk of skin irritation.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 second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this lot.On the basis of this evaluation, a trend does not exist for this lot.The sample had not been received by the site.Severity of harm was s3.Exped trend actions taken: there was deviation from sop-#, complaint trending guidelines, effective 24feb2020 in which the expedite trending of complaint investigations was trended for a 24-month period instead of a 36-month period.This investigation was reopened to correct the trending.The results do not change the root cause of the complaint.Corrections will be completed in pr-#, action item pr-#.Follow-up (17mar2020): new information received from a contactable consumer includes: product trade name, lot number, expiry date, more events detail.Follow-up (20apr2020): new information received from a product complaint group included: investigation results and severity of harm.Follow-up (08may2020): follow-up attempts are completed.No further information is expected.Follow-up (16oct2020): new information received from the product quality complaint group included updated trending information and suspect device was confirmed as thermacare muscle & joint.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events burning sensation, pain in extremity, muscle twitching and device use error 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.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.

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Brand Name

THERMACARE MUSCLE & JOINT

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

9884606

MDR Text Key

189449813

Report Number

1066015-2020-00086

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

Type of Report

Initial,Followup,Followup,Followup

Report Date

03/17/2020

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

11/01/2021

Device Lot Number

AA2377

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

03/26/2020

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided

Supplement Dates FDA Received

03/30/2020
04/28/2020
10/27/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

87 YR

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MUSCLE & JOINT; DISPOSABLE PACK, HOT

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