MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT

Device Problem Overheating of Device (1437)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This investigation was conducted for an unknown lot number joint therapy 8 hour product.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 wrap/patch/pad too hot.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.Final confirmation status: not confirmed.A return sample has not been received at the site for evaluation as of 18nov2019.

Event Description

They used to get so hot she would have to put a handkerchief under them [device issue].Case narrative.The initial case was missing the following minimum criteria: adverse event.Upon receipt of follow-up information on 19nov2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer reporting for herself.A female patient of unspecified age received thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), device lot number and expiry unknown, on an unspecified date "years ago" at an unspecified frequency for an unspecified indication.Medical history and concomitant medications were not reported.The reporter states she bought them years ago when she had a problem and they used to get so hot she would have to put a handkerchief under them.She no longer has product from years ago.The action taken with thermacare and event outcome were unknown.Product quality complaints provided the following summary and conclusion: this investigation was conducted for an unknown lot number joint therapy 8 hour product.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 wrap/patch/pad too hot.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.Final confirmation status: not confirmed.A return sample has not been received at the site for evaluation as of18nov2019.No follow-up attempts are needed.No further information is expected.Company clinical evaluation comment based on the information provided, the event of "they used to get so hot " as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.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.Comment: based on the information provided, the event of "they used to get so hot " as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.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.

Event Description

Event verbatim [preferred term] they used to get so hot she would have to put a handkerchief under them [device issue].Case narrative:the initial case was missing the following minimum criteria: no adverse event, product complaint only.Upon receipt of follow-up information on 19nov2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer reporting for herself.A female patient of unspecified age received thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), device lot number and expiry unknown, on an unspecified date "years ago" at an unspecified frequency for an unspecified indication.Medical history and concomitant medications were not reported.The reporter states she bought them years ago when she had a problem and they used to get so hot she would have to put a handkerchief under them.She no longer has product from years ago.The action taken with thermacare and event outcome were unknown.Product quality complaints provided the following summary and conclusion: this investigation was conducted for an unknown lot number joint therapy 8 hour product.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 wrap/patch/pad too hot.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.Final confirmation status: not confirmed.A return sample has not been received at the site for evaluation as of 18nov2019.Addintianl information received from pqc included: severity of harm: s3.No follow-up attempts are needed.No further information is expected.Follow-up (03dec2019): new information received from product quality complaint group included severity assessment.Company clinical evaluation comment based on the information provided, the patient reported "they used to get so hot" which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.A causal relationship between the device and the device leakage cannot be ruled out.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., comment: based on the information provided, the patient reported "they used to get so hot" which represents a potential device malfunction.There was no adverse reaction such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.A causal relationship between the device and the device leakage cannot be ruled out.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.

Manufacturer Narrative

This investigation was conducted for an unknown lot number joint therapy 8 hour product.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 wrap/patch/pad too hot.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.Final confirmation status: not confirmed.A return sample has not been received at the site for evaluation as of 18nov2019.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 9412503
• MDR Text Key: 187266257
• Report Number: 1066015-2019-00504
• 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: 11/15/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2019
• 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): Required Intervention