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

Lot Number N96880

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

Patient Problem Hyperglycemia (1905)

Event Type  Death  

Event Description

After she wore it for several hours, her blood sugar went up to 350 [blood glucose increased].Case narrative:this is a spontaneous report from a contactable consumer reporting for his wife.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number n96880, expiration date jan2019, upc number: (b)(4)) from an unspecified date for an unspecified indication.Medical history included ongoing diabetic.There were no concomitant medications.The patient wore the product for several hours.After she wore it, her blood sugar went up to 350 on an unspecified date.The caller wanted to know if the use of this product made her blood sugar go up.She would stop using the product if this was the case.She did not require any medical treatment regarding this issue.She controlled her blood sugar using her prescribed medications.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.Follow-up (04jan2017): follow-up attempts are completed.No further information is expected.Follow-up (18nov2016): 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 event of "blood sugar went up to 350" is considered serious medical condition that necessitates medical intervention to preclude serious outcome.A causal relationship between the suspect device and the event cannot be ruled out.This case will be re-assessed should additional information becomes available.Comment: based on the information provided, the event of "blood sugar went up to 350" is considered serious medical condition that necessitates medical intervention to preclude serious outcome.A causal relationship between the suspect device and the event cannot be ruled out.This case will be re-assessed should additional information becomes available.

Event Description

Event verbatim [preferred term] (patient) passed away [death] , after she wore it for several hours, her blood sugar went up to 350 [blood glucose increased] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for his wife.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number n96880, expiration date jan2019, upc number: 305733010969) from an unspecified date for an unspecified indication.Medical history included ongoing diabetic.There were no concomitant medications.The patient wore the product for several hours.After she wore it, her blood sugar went up to 350 on an unspecified date.The caller wanted to know if the use of this product made her blood sugar go up.She would stop using the product if this was the case.She did not require any medical treatment regarding this issue.She controlled her blood sugar using her prescribed medications.The reporter further stated his wife (patient) passed away on unknown date.Action taken with the suspect product was unknown.Clinical outcome of the event "her blood sugar went up to 350" was unknown.The patient died on unknown date.It was unknown whether autopsy was done.Follow-up (04jan2017): follow-up attempts are completed.No further information is expected.Follow-up (18nov2016): 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 event of "blood sugar went up to 350" is considered serious medical condition that necessitates medical intervention to preclude serious outcome.A causal relationship between the suspect device and the event cannot be ruled out.Additional serious event "(patient) passed away" reported.This case will be re-assessed should additional information becomes available.Follow-up (24oct2019): new information received from a contactable consumer included: additional event "(patient) passed away." no follow-up attempts are possible.No further information is expected., comment: based on the information provided, the event of "blood sugar went up to 350" is considered serious medical condition that necessitates medical intervention to preclude serious outcome.A causal relationship between the suspect device and the event cannot be ruled out.Additional serious event "(patient) passed away" reported.This case will be re-assessed should additional information becomes available.

Event Description

Event verbatim [preferred term] (patient) passed away [death] , after she wore it for several hours, her blood sugar went up to 350 [blood glucose increased] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for his wife.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number n96880, expiration date jan2019, upc number: 305733010969) from an unspecified date for an unspecified indication.Medical history included ongoing diabetic.There were no concomitant medications.The patient wore the product for several hours.After she wore it, her blood sugar went up to 350 on an unspecified date.The caller wanted to know if the use of this product made her blood sugar go up.She would stop using the product if this was the case.She did not require any medical treatment regarding this issue.She controlled her blood sugar using her prescribed medications.The reporter further stated his wife (patient) passed away on unknown date.Action taken with the suspect product was unknown.Clinical outcome of the event "her blood sugar went up to 350" was unknown.The patient died on unknown date.It was unknown whether autopsy was done.Product quality results provided the following investigation information: site sample status: not received.Batch n96880 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "after she wore it, her blood sugar went up to 350." the cause of the consumer wore the wrap her blood sugar go up to 350 is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (b)(6) 2017): follow-up attempts are completed.No further information is expected.Follow-up (b)(62016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (b)(6) 2019): new information received from a contactable consumer included: additional event "(patient) passed away".No follow-up attempts are possible.No further information is expected.Follow-up (b)(6) 2020): new information received from a product quality complaint group includes: investigation results.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment based on the information provided, the event of "blood sugar went up to 350" is considered serious medical condition that necessitates medical intervention to preclude serious outcome.A causal relationship between the suspect device and the event cannot be ruled out.Additional serious event "(patient) passed away" reported.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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time., comment: based on the information provided, the event of "blood sugar went up to 350" is considered serious medical condition that necessitates medical intervention to preclude serious outcome.A causal relationship between the suspect device and the event cannot be ruled out.Additional serious event "(patient) passed away" reported.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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time.

Manufacturer Narrative

Site sample status: not received.Batch n96880 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "after she wore it, her blood sugar went up to 350." the cause of the consumer wore the wrap her blood sugar go up to 350 is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

• 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: 9257382
• MDR Text Key: 180441449
• Report Number: 1066015-2019-00275
• 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: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Lot Number: N96880
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/13/2019; 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention