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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Tachycardia (2095)

Event Type  Injury  

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.

Event Description

The moment when thermacare started heating up, the patient noticed his heartbeat speeding up and an uncomfortable stabbing pain in chest [heart rate increased] , an uncomfortable stabbing pain in chest [chest pain] , the moment when thermacare started heating up [device issue] ,.Case narrative:this is a spontaneous report from a contactable health professional.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date, for an unspecified indication.Medical history included placement of a pacemaker.Concomitant medications were not reported.The patient had a pacemaker.It was reported that the moment when thermacare heatwrap started heating up, the patient noticed his heartbeat speeding up and an uncomfortable stabbing pain in chest on an unspecified date.The action taken with thermacare heatwrap and the outcome of the events was unknown.According to the product quality complaint group: 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.Follow-up (28jun2019): follow-up attempts completed.No further information expected.Follow-up (13aug2019): new information received from the product quality complaint group includes investigational results.Follow-up (16aug2019): new information received from the product quality complaint group includes: investigation information.Follow-up (23sep2019): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (03may2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events heart rate increased, chest pain and device issue 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., comment: based on the information provided, the events heart rate increased, chest pain and device issue 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.

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.

Event Description

Event verbatim [preferred term] the moment when thermacare started heating up, the patient noticed his heartbeat speeding up and an uncomfortable stabbing pain in chest [heart rate increased] , an uncomfortable stabbing pain in chest [chest pain] , the moment when thermacare started heating up [device issue] ,.Case narrative:this is a spontaneous report from a contactable health professional.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date, for an unspecified indication.Medical history included placement of a pacemaker.Concomitant medications were not reported.The patient had a pacemaker.It was reported that the moment when thermacare heatwrap started heating up, the patient noticed his heartbeat speeding up and an uncomfortable stabbing pain in chest on an unspecified date.The action taken with thermacare heatwrap and the outcome of the events was unknown.According to the product quality complaint group: 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.Follow-up (28jun2019): follow-up attempts completed.No further information expected.Follow-up (13aug2019): new information received from the product quality complaint group includes investigational results.Follow-up (16aug2019): new information received from the product quality complaint group includes: investigation information.Follow-up (23sep2019): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (03may2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (24dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Company clinical evaluation comment: based on the information provided, the events heart rate increased, chest pain and device issue 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., comment: based on the information provided, the events heart rate increased, chest pain and device issue 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.

Event Description

Event verbatim [preferred term] the moment when thermacare started heating up, the patient noticed his heartbeat speeding up and an uncomfortable stabbing pain in chest [heart rate increased] , an uncomfortable stabbing pain in chest [chest pain] , the moment when thermacare started heating up [device issue].Case narrative:this is a spontaneous report from a contactable health professional.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date, for an unspecified indication.Medical history included placement of a pacemaker.Concomitant medications were not reported.The patient had a pacemaker.It was reported that the moment when thermacare heatwrap started heating up, the patient noticed his heartbeat speeding up and an uncomfortable stabbing pain in chest on an unspecified date.The action taken with thermacare heatwrap and the outcome of the events was unknown.According to the product quality complaint group: 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.Follow-up (28jun2019): follow-up attempts completed.No further information expected.Follow-up (13aug2019): new information received from the product quality complaint group includes investigational results.Follow-up (16aug2019): new information received from the product quality complaint group includes: investigation information.Follow-up (23sep2019): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (03may2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (24dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (07feb2020): this follow-up is being submitted to notify that the investigation is closed; no further results are expected.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events heart rate increased, chest pain and device issue 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.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

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.

• 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: 9261099
• MDR Text Key: 184823054
• Report Number: 1066015-2019-00404
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2019

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/31/2019; 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention