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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Event verbatim [preferred term] got blisters it burned his back [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer on behalf of her husband through a pfizer sponsored program, thermacare.Com testimonials.A male patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from an unspecified date for an unspecified indication.Relevant medical history and concomitant medications were not reported.The reporter stated "my husband got blisters it burned his back" on an unspecified date.The action taken in response to the event for thermacare heatwrap and outcome was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "got blisters it burned his back" 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., comment: based on the information provided, the event of "got blisters it burned his back" 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.

Event Description

Event verbatim [preferred term] got blisters it burned his back [burns second degree] ,.Case narrative:this is a spontaneous report from a contactable consumer on behalf of her husband through a pfizer sponsored program, thermacare.Com testimonials.A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip heatwrap), via an unspecified route of administration from an unspecified date for an unspecified indication.Relevant medical history and concomitant medications were not reported.The reporter stated "my husband got blisters it burned his back" on an unspecified date.The action taken in response to the event for thermacare heatwrap and outcome was unknown.Product investigation results are as follows: an evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage and investigation (citi) search was performed.Scope: date contacted: (b)(6)2014 through (b)(6)2017/manufacturing site: (site name)/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The citi search returned a total 222 complaint for the lower back/hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclasses show a seasonality increase in mar2015, jan2016, feb2016, apr2016, nov2016 through apri2017.Four of the 6 complaints received in may2015 were related to burns, blisters and wrap too hot.Eight of the 12 complaints received in april 2016 were related to burns and blisters.Five of the 8 complaints received in aug2016 were related to burns, blisters, redness and irritation.Eleven of the 13 complaints received in sep2016 were related to burns, blisters and wrap too hot.Twelve of the 16 complaints received in may 2017 were related to burns, blisters and irritation.A change in safety's procedure has incorporated requesting site investigations for complaints with or without batch number; thus, representing a shift in the expected baseline and an overall increase of subsequent complaints received at the site.Based on this citi search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products.There is no further action required.Conclusion: 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.Reasonably suggest device malfunction: no.Site sample status: not received.Follow-up (18feb2019): follow-up attempts are completed.No further information is expected.Follow up (27oct2019): follow-up attempts are completed.No further information is expected.Follow-up (19feb2020): new information received from a product quality complaints group includes product investigation results., comment: based on the information provided, the event of "got blisters it burned his back" 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.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

An evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage and investigation (citi) search was performed.Scope: date contacted: (b)(6)2014 through (b)(6)2017/manufacturing site: (site name)/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The citi search returned a total 222 complaint for the lower back/hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclasses show a seasonality increase in mar2015, jan2016, feb2016, apr2016, nov2016 through apri2017.Four of the 6 complaints received in may2015 were related to burns, blisters and wrap too hot.Eight of the 12 complaints received in april 2016 were related to burns and blisters.Five of the 8 complaints received in aug2016 were related to burns, blisters, redness and irritation.Eleven of the 13 complaints received in sep2016 were related to burns, blisters and wrap too hot.Twelve of the 16 complaints received in may 2017 were related to burns, blisters and irritation.A change in safety¿s procedure has incorporated requesting site investigations for complaints with or without batch number; thus, representing a shift in the expected baseline and an overall increase of subsequent complaints received at the site.Based on this citi search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products.There is no further action required.Conclusion: 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 thi.

• 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: 6740002
• MDR Text Key: 80917015
• Report Number: 1066015-2017-00124
• 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: 07/17/2017

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: 07/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention