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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 11/09/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] my skin was burned all across my back with 3 semi large open blisters/the whole area is quite painful/i felt a sharp pain [burns second degree].Case narrative:this is a spontaneous report from a pfizer sponsored program thermacare (b)(6) page from a contactable consumer.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare lower back & hip), lot number and expiration date was unknown, from an unspecified date for back injury.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient previously took thermacare lower back & hip and thermacare menstrual and not experienced any adverse event.The patient reported that "i hurt my lower back and ran to the nearest (pharmacy name) to pick up your lower back wraps.I wore one for a little while yesterday ((b)(6) 2017) and it helped quite a bit.This morning i put one before work (around 8:30 am) and a little while ago (around noon) while sitting at my desk, i felt a sharp pain.I reached around to feel my skin under the wrap and it burned so bad like i had touched an open wound.I checked my hand for blood because i had no idea what happened and ran to the bathroom to take off the wrap.When i removed it, my skin was burned all across my back with 3 semi large open blisters.The whole area is quite painful.As you can imagine, i'm quite upset about this seeing as how i was already in pain which is why i was using your product to begin with.The heat wasn't too hot nor do i have sensitive skin.It almost feels as though there is chemical on my back burning me." events outcome was unknown.No follow-up attempts are possible.An investigation of the device could not be conducted.Company clinical evaluation comment: based on the information provided, the event of "my skin was burned all across my back with 3 semi large open blisters/the whole area is quite painful/i felt a sharp pain" is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.This event is 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 information provided, the event of "my skin was burned all across my back with 3 semi large open blisters/the whole area is quite painful/i felt a sharp pain" is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.This event is 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.

Event Description

Event verbatim [preferred term] my skin was burned all across my back with 3 semi large open blisters/the whole area is quite painful/i felt a sharp pain [burns second degree].Case narrative: this is a spontaneous report from a pfizer sponsored program thermacare facebook page from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), lot number and expiration date were unknown, from an unspecified date as she hurt her lower back.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient previously took thermacare lower back & hip and thermacare menstrual and not experienced any adverse event.The patient reported that "i hurt my lower back and ran to the nearest (pharmacy name) to pick up your lower back wraps.I wore one for a little while yesterday (b)(6) 2017 and it helped quite a bit.This morning i put one before work (around 8:30 am) and a little while ago (around noon) while sitting at my desk, i felt a sharp pain.I reached around to feel my skin under the wrap and it burned so bad like i had touched an open wound.I checked my hand for blood because i had no idea what happened and ran to the bathroom to take off the wrap.When i removed it, my skin was burned all across my back with 3 semi large open blisters.The whole area is quite painful.As you can imagine, i'm quite upset about this seeing as how i was already in pain which is why i was using your product to begin with.The heat wasn't too hot nor do i have sensitive skin.It almost feels as though there is chemical on my back burning me." the action taken for the product and event outcome was unknown.Product quality complaints provided the following investigation information: there was no reasonable suggestion of device malfunction.A sample was not received at the site.Based on citi search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products a trend for the subclass of adverse event safety request for investigation with product type of lower back/hip (lbh) 8 hour products was not identified.This investigation was conducted for an unknown lot number lower back/hip (lbh) 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 adverse event safety request for investigation.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.No follow-up attempts are possible.An investigation of the device could not be conducted.Follow-up (03mar2020): new information received from a product quality complaint group includes: investigation results.No follow-up attempts are possible.No further information is expected.Comment: based on the information provided, the event of "my skin was burned all across my back with 3 semi large open blisters/the whole area is quite painful/i felt a sharp pain" is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.This event is 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.

Manufacturer Narrative

There was no reasonable suggestion of device malfunction.A sample was not received at the site.Based on citi search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products a trend for the subclass of adverse event safety request for investigation with product type of lower back/hip (lbh) 8 hour products was not identified.This investigation was conducted for an unknown lot number lower back/hip (lbh) 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 adverse event safety request for investigation.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 was not confirmed.

• 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: 7033164
• MDR Text Key: 92068897
• Report Number: 1066015-2017-00161
• 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: 11/09/2017

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: 11/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention