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

Device Problem Temperature Problem (3022)

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

Event Type  Injury  

Event Description

Event verbatim [preferred term] after a short time his back was burned/blisters could be recognized from photo of the burn [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer received via pfizer-sponsored program "brand websites for division consumer healthcare (b)(6)".A male patient of unknown age started to receive thermacare heatwrap (thermacare lower back & hip) from unknown date for unknown indication.Medical history and concomitant medications were not reported.The patient wanted to try thermacare belt and after a short time his back was burned.He never reacted to something like that, neither to heat cream nor to others.The patient provided also a photo of the burn, on which blisters could be recognized.The action taken in response to the event of the product 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.

Manufacturer Narrative

An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 12/21/2015 through 12/21/2018/manufacturing site: pfizer (name)/complaint class: wrap/parch/pad/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 259 complaints for lower back and hip products during this time period for the class/subclass.Of the 259 complaints; 30 complaints have the batch number recorded as "unknown." the 229 remaining complaints were evaluated.They were not confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom 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.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products.The root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.Our 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.

Event Description

After a short time his back was burned/blisters could be recognized from photo of the burn [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer received via pfizer-sponsored program "brand websites for devision consumer healthcare germany".A male patient of unknown age started to receive thermacare heatwrap (thermacare lower back & hip) from unknown date for unknown indication.Medical history and concomitant medications were not reported.The patient wanted to try thermacare belt and after a short time his back was burned.He never reacted to something like that, neither to heat cream nor to others.The patient provided also a photo of the burn, on which blisters could be recognized.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Upon follow-up product quality complaints provided the following investigation report: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 12/21/2015 through 12/21/2018/manufacturing site: pfizer albany/complaint class: wrap/parch/pad/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 259 complaints for lower back and hip products during this time period for the class/subclass.Of the 259 complaints; 30 complaints has the batch number recorded as "unknown." the 229 remaining complaints were evaluated.They were not confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom 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.Based on this pcom search for the subclass of adverse event safety request for investigation for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event safety request for investigation for lbh products.The root cause category is non-assignable (complaint not confirmed).The product effect may vary with each individual.Our 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.Additional information has been requested and will be provided as it becomes available.Follow-up (29jan2019): new information reported from product quality complaints includes: investigation report.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.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 "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.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: 8195769
• MDR Text Key: 131481684
• Report Number: 1066015-2018-00206
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

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: 12/26/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention