MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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

Patient Problem Death (1802)

Event Type  Death  

Event Description

Her husband who died, he used it all the time [death].Case description: this is a spontaneous report from a contactable consumer.A male patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the reporter stated "she and her husband who died, he used it all the time." the patient died on an unspecified date.It was not reported if an autopsy was performed.Action taken with the suspect product was unknown.Clinical outcome of the event was fatal.Follow-up (16may2016): follow-up attempts completed.No further information expected.Follow-up (05apr2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: there is very limited information with regard to the cause of the death of the patient in this report.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.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 9263822
• MDR Text Key: 164574069
• Report Number: 1066015-2019-00254
• 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: Other
• Type of Report: Initial
• Report Date: 04/05/2016

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
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 10/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention