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

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

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

Event Description

Event verbatim [preferred term] heart attack [myocardial infarction].Case narrative: this is a spontaneous report from a non-contactable consumer or other non hcp.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date to an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported she has been using the thermacare heatwraps for a long time and she had a heart attack 3 years ago (unspecified date in 2016) and continued to use the wraps.Action taken with the suspect product was unknown.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 limited information, the event of "heart attack 3 years ago" as described is considered serious medically significant event and the company cannot exclude a possible association between the event and the use of the device., comment: based on the limited information, the event of "heart attack 3 years ago" as described is considered serious medically significant event and the company cannot exclude a possible association between the event and the use of the device.

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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 additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.

Event Description

Event verbatim [preferred term] heartattack [myocardial infarction] ,.Case narrative:this is a spontaneous report from a non-contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported she has been using the thermacare heatwraps for a long time and she had a heart attack 3 years ago (unspecified date in 2016) and continued to use the wraps.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.The 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 additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.Follow up ((b)(6)2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow up ((b)(6)2019): new information received from product quality complaints (pqc) group included: additional product quality investigation results.No follow-up attempts possible.No further information is expected.Company clinical evaluation comment: there is very limited information with regard to the reported event of "heart attack 3 years ago" of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported myocardial infarction at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), concomitant medications, and other risk factors that could have contributed to the above reported event. the company conducted an investigation, there was no quality defect or issue.No device malfunction has been identified.No further investigations or actions is suggested at this time., comment: there is very limited information with regard to the reported event of "heart attack 3 years ago" of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported myocardial infarction at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), concomitant medications, and other risk factors that could have contributed to the above reported event.The company conducted an investigation, there was no quality defect or issue.No device malfunction has been identified.No further investigations or actions is suggested at this time.

Manufacturer Narrative

Introduction: thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaints where there is no quality defect.A non-defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.Complaint handling for non-defect subclass: complaints received at the site in the global complaint database related to non-defect will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to a non- defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.

Event Description

Event verbatim [preferred term] heartattack [myocardial infarction].Case narrative:this is a spontaneous report from a non-contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) from an unspecified date to an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported she has been using the thermacare heatwraps for a long time and she had a heart attack 3 years ago (unspecified date in 2016) and continued to use the wraps.Action taken with the suspect product was unknown.Clinical outcome of the event was unknown.According to product quality complaint group: introduction: thermacare heat wraps are premium topical heat therapy products.The heat wraps are worn against the body or over a layer of clothing to relieve minor muscular and joint aches and pains.The (site name) is the sole manufacturing location for thermacare heat wraps.They are produced on two manufacturing lines; the b line produces the larger products which wrap around the body with stretch materials, and the m line produces the smaller products that are attached for use with pressure sensitive adhesives.The purpose of this document is to summarize customer complaints where there is no quality defect.A non-defect complaint represents a suggestion/concern about the existing product that does not include a product quality issue, but is related to a suggestion for improvement.Complaint handling for non-defect subclass: complaints received at the site in the global complaint database related to non-defect will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to a non- defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.Follow up (01apr2019): new information received from product quality complaints groups included: investigation results.Company clinical evaluation comment: there is very limited information with regard to the reported event of "heart attack 3 years ago" of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported myocardial infarction at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), concomitant medications, and other risk factors that could have contributed to the above reported event. the company conducted an investigation, there was no quality defect or issue.No device malfunction has been identified.No further investigations or actions is suggested at this time., comment: there is very limited information with regard to the reported event of "heart attack 3 years ago" of the patient in this report.Additional information could not be obtained as the reporter declined to be contacted for follow-up.Based on the limited information, the company cannot exclude a possible association between the use of the suspect device and the reported myocardial infarction at this time, until sufficient information is available to provide a medically meaningful assessment.In particular, the following relevant information is missing: the patient's demographics, medical history, concurrent medical condition(s), concomitant medications, and other risk factors that could have contributed to the above reported event.The company conducted an investigation, there was no quality defect or issue.No device malfunction has been identified.No further investigations or actions is suggested at this time.

• 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: 8417968
• MDR Text Key: 138896649
• Report Number: 1066015-2019-00065
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/09/2019; 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention