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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Tingling (2171); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

A stinging sensation and there were two blisters already formed/burn me [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at unknown frequency for pain on left side.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient stated "i've punched the thermacare heatwraps from my local (store name) because i have pain on my left side.I followed the directions on how to apply it.I took it off after six hours because i've felt a stinging sensation and there were two blisters already formed.I've purchased your product to relieve my pain, not to burn me and increase my pain".The action taken in response to the event was unknown.The outcome of the event 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 "burn blisters" 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 "burn blisters" 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] a stinging sensation and there were two blisters already formed/burn me [burns second degree], , narrative: this is a spontaneous report from a contactable consumer.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date at unknown frequency for pain on left side.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient stated "i've punched the thermacare heatwraps from my local (store name) because i have pain on my left side.I followed the directions on how to apply it.I took it off after six hours because i've felt a stinging sensation and there were two blisters already formed.I've purchased your product to relieve my pain, not to burn me and increase my pain".The action taken in response to the event was unknown.The outcome of the event was unknown.Product investigation results were as follows: scope: date contacted: (b)(6) 2015 through (b)(6)2018/ manufacturing site: pfizer albany/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The citi search returned a total 416 complaints for the lower back and hip (lbh) products during this time period for the class/subclass adverse event safety request for investigation.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows a seasonality increase in (b)(6)2016, (b)(6)2016, (b)(6) 2016, (b)(6)2016 through (b)(6)2017, (b)(6)2017 through apr2018.A change in safety's procedure updated on 20aug2018 that 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.Eleven of the 19 complaints received in (b)(6) 2017 were related to burns, redness, irritation and blisters.The data shows a spike of 32 complaints received in (b)(6)2017; twenty -one of the 32 were related to burns, rash, blisters, irritation and wrap too hot.Seventeen of the 20 complaint received in (b)(6)2017 were related to burns, redness, blisters, irritation and allergic reaction.Based on this citi search, there is not a trend identified for the subclass of adverse event safety request for investigation.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, 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.A return sample has not been received at the site for evaluation as of (b)(6)2020.Follow-up (29mar2019): follow-up attempts are completed.No further information is expected.Follow-up (27may2020): new information received from a product quality complaint group includes: product investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event of "burn blisters" 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.

Manufacturer Narrative

Scope: date contacted: 09sep2015 through 09sep2018/ manufacturing site: pfizer albany/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The citi search returned a total 416 complaints for the lower back and hip (lbh) products during this time period for the class/subclass adverse event safety request for investigation.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The subclass shows a seasonality increase in (b)(6) 2016, (b)(6)2016, (b)(6)2016 , (b)(6)2016 through (b)(6)2017, (b)(6)2017 through (b)(6)2018.A change in safety¿s procedure updated on (b)(6)2018 that 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.Eleven of the 19 complaints received in(b)(6) 2017 were related to burns, redness, irritation and blisters.The data shows a spike of 32 complaints received in (b)(6) 2017; twenty -one of the 32 were related to burns, rash, blisters, irritation and wrap too hot.Seventeen of the 20 complaint received in (b)(6)2017 were related to burns, redness, blisters, irritation and allergic reaction.Based on this citi search, there is not a trend identified for the subclass of adverse event safety request for investigation.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, 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.A return sample has not been received at the site for evaluation as of (b)(6)2020.

• 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: 7870459
• MDR Text Key: 120099328
• Report Number: 1066015-2018-00105
• 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: 09/09/2018

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention