MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT

Lot Number M73592

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Contusion (1787); Injury (2348)

Event Date 04/26/2016

Event Type  Injury  

Event Description

The black and blue mark on his arm had gotten a little bigger [contusion].The black and blue mark on his arm had gotten a little bigger [condition aggravated].Wrap was too hot [product quality issue].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A male patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: m73592, expiration date: jan2019) from an unspecified date for an unspecified indication.The patient's medical history included contusion from an unknown date and unknown if ongoing (reported as "he thinks he bruised his arm before heatwrap and had a little black and blue").Concomitant medications were not reported.On (b)(6) 2016, the patient reported he put the heatwrap on his left upper arm, with no protection, for 8 hours and the black and blue mark on his arm had gotten a little bigger.The next day, (b)(6) 2016, he applied the product on his arm in the same area with no protection to his skin and he felt a little heat which was comfortable.At the end of the 8 hours, he took the heatwrap off and his arm was a bigger black and blue.The black and blue is about 3x3 inches, maybe 4x4 inches.The patient reported he also put another wrap from the box on his back which was too hot.He mentioned he put a hanky in between his skin and the wrap on his back, and that was better.Action taken with the suspect product was not reported.Clinical outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment based on the information provided, the events the black and blue mark on his arm had gotten a little bigger and condition aggravated as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product quality issue assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events the black and blue mark on his arm had gotten a little bigger and condition aggravated as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product quality issue assessed as associated with the device use.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include statistical sampling, 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 plant has reviewed this batch from a manufacturing and technical perspective.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Case description: this is a spontaneous report from a contactable consumer.A male patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain); (device lot number: m73592, expiration date: jan2019) from an unspecified date for an unspecified indication.The patient's medical history included contusion from an unknown date and unknown if ongoing (reported as "he thinks he bruised his arm before heatwrap and had a little black and blue").Concomitant medications were not reported.On (b)(6) 2016, the patient reported he put the heatwrap on his left upper arm, with no protection, for 8 hours and the black and blue mark on his arm had gotten a little bigger.The next day, (b)(6) 2016, he applied the product on his arm in the same area with no protection to his skin and he felt a little heat which was comfortable.At the end of the 8 hours, he took the heatwrap off and his arm was a bigger black and blue.The black and blue is about 3x3 inches, maybe 4x4 inches.The patient reported he also put another wrap from the box on his back which was too hot.He mentioned he put a hanky in between his skin and the wrap on his back, and that was better.Action taken with the suspect product was not reported.Clinical outcome of the events was not resolved.Based on investigation results, the root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include statistical sampling, 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 plant has reviewed this batch from a manufacturing and technical perspective.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (14jun2016): new information received from product quality complaint group included: product investigation result.Company clinical evaluation comment based on the information provided, the events the black and blue mark on his arm had gotten a little bigger and condition aggravated as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product quality issue assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events the black and blue mark on his arm had gotten a little bigger and condition aggravated as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product quality issue assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Evaluation summary: the root cause category is non-assignable (complaint not confirmed).Our manufacturing operations employ quality control procedures which include statistical sampling, 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 plant has reviewed this batch from a manufacturing and technical perspective.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Our manufacturing operations employ quality control procedures which include statistical sampling, 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 plant has reviewed this batch from a manufacturing and technical perspective.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Case description: this is a spontaneous report from a contactable consumer.A male patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: m73592, expiration date: jan2019) from an unspecified date for an unspecified indication.The patient's medical history included contusion from an unknown date and unknown if ongoing (reported as "he thinks he bruised his arm before heatwrap and had a little black and blue").Concomitant medications were not reported.On (b)(6) 2016, the patient reported he put the heatwrap on his left upper arm, with no protection, for 8 hours and the black and blue mark on his arm had gotten a little bigger.The next day, (b)(6) 2016, he applied the product on his arm in the same area with no protection to his skin and he felt a little heat which was comfortable.At the end of the 8 hours, he took the heatwrap off and his arm was a bigger black and blue.The black and blue is about 3x3 inches, maybe 4x4 inches.The patient reported he also put another wrap from the box on his back which was too hot.He mentioned he put a hanky in between his skin and the wrap on his back, and that was better.Action taken with the suspect product was not reported.Clinical outcome of the events was not resolved.Based on investigation results, the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Our manufacturing operations employ quality control procedures which include statistical sampling, 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 plant has reviewed this batch from a manufacturing and technical perspective.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (14jun2016): new information received from product quality complaint group included: product investigation result.Follow-up (24jun2016): follow-up attempts are completed.No further information is expected.Follow up (24jun2016):new information received from product quality complaint group included: additional product investigation result.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events the black and blue mark on his arm had gotten a little bigger and condition aggravated as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product quality issue assessed as associated with the device use.This case meets final 1 0-day eu and 30-day fda reportability.Continued: evaluation summary: the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Our manufacturing operations employ quality control procedures which include statistical sampling, 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 plant has reviewed this batch from a manufacturing and technical perspective.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Case description: this is a spontaneous report from a contactable consumer.A male patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: m73592, expiration date: jan2019) from an unspecified date for an unspecified indication.The patient's medical history included contusion from an unknown date and unknown if ongoing (reported as "he thinks he bruised his arm before heatwrap and had a little black and blue").Concomitant medications were not reported.On (b)(6) 2016, the patient reported he put the heatwrap on his left upper arm, with no protection, for 8 hours and the black and blue mark on his arm had gotten a little bigger.The next day, (b)(6) 2016, he applied the product on his arm in the same area with no protection to his skin and he felt a little heat which was comfortable.At the end of the 8 hours, he took the heatwrap off and his arm was a bigger black and blue.The black and blue is about 3x3 inches, maybe 4x4 inches.The patient reported he also put another wrap from the box on his back which was too hot.He mentioned he put a hanky in between his skin and the wrap on his back, and that was better.Action taken with the suspect product was not reported.Clinical outcome of the events was not resolved.While on follow-up, reporter reported "all ok".Based on investigation results, the root cause category is non-assignable (complaint not confirmed).The plant has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Our manufacturing operations employ quality control procedures which include statistical sampling, 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 plant has reviewed this batch from a manufacturing and technical perspective.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges wrap was too hot.The cause of the alleged wrap being too hot is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (14jun2016): new information received from product quality complaint group included: product investigation result.Follow-up (24jun2016): follow-up attempts are completed.No further information is expected.Follow up (24jun2016):new information received from product quality complaint group included: additional product investigation result.Follow-up attempts completed.No further information expected.Company clinical evaluation comment based on the information provided, the events the black and blue mark on his arm had gotten a little bigger and condition aggravated as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product quality issue assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Follow-up (11jul2016): new information received from the contactable consumer included: all ok.Follow-up attempts completed.No further information expected.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: b green ; 235 e42nd street; new york, NY 10017 ; 2127334552
• MDR Report Key: 5676488
• MDR Text Key: 45964378
• Report Number: 1066015-2016-00083
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Lot Number: M73592
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/24/2016; 07/19/2016; 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention