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 Death (1802)

Event Type  Death  

Event Description

Husband used the thermacare products before he died [death].Case narrative: this is a spontaneous report from a non-contactable consumer reporting for husband.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap) from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The reporter stated that her husband used the thermacare products before he died on an unspecified date.No further information was provided.Action taken in response to the event was unknown, the outcome of the event was fatal.It was not reported if an autopsy was performed.Follow-up (06dec2019): this follow-up report is being submitted as a reportable mdr.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: there is very limited information with regard to the cause of the death 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 death (unknown cause) 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), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise.This case will be re-assessed when additional information becomes available.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).Since there was no batch number or return sample available for evaluation, there was limited device specific information provided to evaluate.A batch reference number and/or return sample is needed to complete a manufacturing and technical evaluation for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event safety request for investigation with the product type of lower back and hip (lbh) products.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] husband used the thermacare products before he died [death] ,.Case narrative:this is a spontaneous report from a non-contactable consumer reporting for husband.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) (device lot number unavailable) from an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The reporter stated that she has used the thermacare lower back and hip products in the last 5 or 10 years, she doesn't remember exactly.She no longer has those products.The reporter stated that her husband used the thermacare products before he died on an unspecified date.No further information was provided.Action taken in response to the event was unknown.The outcome of the event was fatal.It was not reported if an autopsy was performed.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).Since there was no batch number or return sample available for evaluation, there was limited device specific information provided to evaluate.A batch reference number and/or return sample is needed to complete a manufacturing and technical evaluation for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event safety request for investigation with the product type of lower back and hip (lbh) products.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 (06dec2019): this follow-up report is being submitted as a reportable mdr.Additional information has been requested and will be provided as it becomes available.Follow-up (12apr2019): new information received from product quality complaints (pqc) group included: updated the suspect product and provided the product quality investigation results.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment: there is very limited information with regard to the cause of the death 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 death (unknown cause) 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), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise., comment: there is very limited information with regard to the cause of the death 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 death (unknown cause) 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), clinical course prior to the death of the patient, concomitant medications, and other risk factors that could have contributed to the patient's demise.

• 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: 8495511
• MDR Text Key: 141341838
• Report Number: 1066015-2018-00187
• 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
• Report Date: 12/06/2018

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: 04/09/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other