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

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 02/01/2007

Event Type  Injury  

Event Description

Multiple myeloma cancer [plasma cell myeloma] , many of the chemos he took caused back and spine pain [back pain] , many of the chemos he took caused back and spine pain [spinal pain] , wore the wrap for 8-10 hours/reason for taking: spinal scoliosis [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer (patient).An adult male patient started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date for over 20 years at 1 or 2 a day for spinal scoliosis as teen.Co-suspect product included unspecified chemos.The patient medical history was not reported.There were none concomitant medications.He has had multiple myeloma cancer since (b)(6) 2007 and many of the chemos he took caused back and spine pain.All his doctors knew he used thermacare product.The patient had issues with thermacare lower back & hip not sticking properly and falling off.The wrap covered his pain area, but it went around his body to hook up and that was what caused to fall off.He wore the wrap for 8-10 hours.He stopped using thermacare lower back & hip from an unspecified date.He started to use muscle heatwrap (muscle pain therapy) from (b)(6) 2018 and joint heatwrap (joint pain therapy) from (b)(6) 2018.Muscle heat wrap fit perfectly on the back waist/spine where his pain exists daily.The patient was not hospitalized and did not receive any treatment in response to "he had issue with it not sticking properly and falling off".The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was unknown.Follow-up (14nov2018): new information received from a contactable consumer includes: age group, suspect device start date, frequency, indication, action taken, co-suspect product, new events multiple myeloma cancer, back and spine pain.The case upgraded to serious.Follow-up (03apr2019): follow-up attempts are completed.No further information is expected.Follow-up (14nov2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the available information, the event multiple myeloma is considered serious medical condition.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 available information, the event multiple myeloma is considered serious medical condition.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.

Manufacturer Narrative

Malfunction was reasonable suggested.A sample was not received at the site.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 adhesion/fastening defect.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 package.

Event Description

Event verbatim [preferred term] multiple myeloma cancer [plasma cell myeloma] , wore the wrap for 8-10 hours/reason for taking: spinal scoliosis [device use error] , many of the chemos he took caused back and spine pain [back pain] , many of the chemos he took caused back and spine pain [spinal pain].Case narrative:this is a spontaneous report from a contactable consumer (patient).An adult male patient started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date for over 20 years at 1 or 2 a day for spinal scoliosis as teen.Co-suspect product included unspecified chemos.The patient's medical history was not reported.There were no concomitant medications.He has had multiple myeloma cancer since (b)(6) 2007 and many of the chemos he took caused back and spine pain.All his doctors knew he used thermacare product.The patient had issues with thermacare lower back & hip not sticking properly and falling off.The wrap covered his pain area, but it went around his body to hook up and that was what caused to fall off.He wore the wrap for 8-10 hours.He stopped using thermacare lower back & hip from an unspecified date.He started to use muscle heatwrap (muscle pain therapy) from (b)(6) 2018 and joint heatwrap (joint pain therapy) from (b)(6) 2018.Muscle heat wrap fit perfectly on the back waist/spine where his pain exists daily.The patient was not hospitalized and did not receive any treatment in response to "he had issue with it not sticking properly and falling off".The action taken in response to the events for thermacare heatwrap was permanently withdrawn on an unspecified date.The outcome of the events was unknown.Product quality complaints provided the following investigation information for complaint subclass of adhesion/ fastening defect: malfunction was reasonable suggested.A sample was not received at the site.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 adhesion/fastening defect.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 package.Follow-up (14nov2018): new information received from a contactable consumer includes: age group, suspect device start date, frequency, indication, action taken, co-suspect product, new events multiple myeloma cancer, back and spine pain.The case upgraded to serious.Follow-up (03apr2019): follow-up attempts are completed.No further information is expected.Follow-up (14nov2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (04dec2019): new information received from a product quality complaint group includes: investigation results.Company clinical evaluation comment: based on the available information, the event multiple myeloma is considered serious medical condition.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.The other evens device use error, back pain and spinal pain are non-serious and 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., comment: based on the available information, the event multiple myeloma is considered serious medical condition.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.The other evens device use error, back pain and spinal pain are non-serious and 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.

• 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: 9260676
• MDR Text Key: 184811231
• Report Number: 1066015-2019-00257
• 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: 10/24/2018

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?: 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
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention