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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pressure Sores (2326); Partial thickness (Second Degree) Burn (2694)

Event Date 03/30/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] back is burnt up/second degree burn, blisters on the left and on the right side [burns second degree]; got two huge sores [wound]; it was hot [device issue].Case narrative:this is a spontaneous report from a contactable nurse reporting on behalf of her mother.An other ethnic group female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from (b)(6) 2017 for really bad back problems and pulled muscle.Medical history included unspecified surgery from an unknown date and unknown if ongoing (the middle of her back dipped in as she had surgery before).There were no concomitant medications.On (b)(6) 2017, the reporter stated her mother purchased heatwraps that go on your back, used the heatwraps for the first time, and her back is burnt up, shocking blistered, like deep.The reporter stated the burns are on the bottom part of her back, blisters on the left and on the right side.She mentioned her mother put it on at work and just sat throughout the day and just thought it was hot.When she took it off, she got two huge sores.The reporter thought it was probably a second degree burn.She expected her mother to experience long-term sequelae such as scarring.She stated it just started to heal but she might have to go to the hospital.Therapeutic measures taken included neosporin and keeping it clean with soap and water.No surgical intervention, such as debridement, was required.No lab results were reported.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.Clinical outcome of the events was resolving.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the reported events burn blister, wound, and device issue as described in this case are considered serious bodily injuries/unanticipated serious deterioration requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device., comment: based on the information provided, the reported events burn blister, wound, and device issue as described in this case are considered serious bodily injuries/unanticipated serious deterioration requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Manufacturer Narrative

Complaint not confirmed.An evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date of contact: (b)(6)2014 through (b)(6)2017/manufacturing site: pfizer albany/complaint class: product use attributes/ complaint sub class: wrap/patch/pad too hot.The citi search returned a total of 146 complaints for lower back/hip (lbh) 8 hour products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of wrap/patch/pad too hot.The subclass show a seasonality increase in the months apr2014, jan2015, mar2015 jan2016.Seven of the 15 complaints received in apr2014 were adverse event related.Two of the 10 complaint received in january 2015 were adverse event related.Five of the 10 complaints received in march 2015 were adverse event related.A review of the 36 month trend chart shows a spike in september 2016 that may be attributed to a literature case /cep study.A citi complaint trend search was conducted for the subclass wrap/patch/pad too hot for lbh 8hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass wrap/patch/pad too hot for lbh 8hr products.There is no further action required.Based on this citi customizable search for the subclasses of wrap/patch/pad too hot for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of wrap/patch/pad too hot for lbh product.Site sample status: not received.Reasonably suggest device malfunction: no; severity of harm: n/a.

Event Description

Event verbatim [preferred term] back is burnt up/second degree burn, blisters on the left and on the right side/got two huge sores [burns second degree] , it was hot [device issue].Case narrative:this is a spontaneous report from a contactable nurse reporting on behalf of her mother.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) from (b)(6) 2017 for really bad back problems and pulled muscle.Medical history included unspecified surgery from an unknown date (the middle of her back dipped in as she had surgery before).There were no concomitant medications.On (b)(6) 2017, the reporter stated her mother purchased heatwraps that go on your back, used the heatwraps for the first time, and her back is burnt up, shocking blistered, like deep.The reporter stated the burns are on the bottom part of her back, blisters on the left and on the right side.She mentioned her mother put it on at work and just sat throughout the day and just thought it was hot.When she took it off, she got two huge sores.The reporter thought it was probably a second degree burn., looked very deep.She expected her mother to experience long-term sequelae such as scarring.She stated it just started to heal but she might have to go to the hospital.Therapeutic measures taken included neosporin and keeping it clean with soap and water.No surgical intervention, such as debridement, was required.No lab results were reported.She didn't think the patient even has the box.Action taken with the suspect product was permanently withdrawn on (b)(6) 2017.Clinical outcome of the events was resolving.Per the product quality group: complaint not confirmed.An evaluation was made by searching for possible trend for this subclass.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date of contact: (b)(6)2014 through (b)(6)2017/manufacturing site: pfizer albany/complaint class: product use attributes/ complaint sub class: wrap/patch/pad too hot.The citi search returned a total of 146 complaints for lower back/hip (lbh) 8 hour products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of wrap/patch/pad too hot.The subclass show a seasonality increase in the months apr2014, jan2015, mar2015 jan2016.Seven of the 15 complaints received in apr2014 were adverse event related.Two of the 10 complaint received in january 2015 were adverse event related.Five of the 10 complaints received in march 2015 were adverse event related.A review of the 36 month trend chart shows a spike in september 2016 that may be attributed to a literature case /cep study.A citi complaint trend search was conducted for the subclass wrap/patch/pad too hot for lbh 8hr products.The data did not show an increase over time (36 months).There is not a trend identified for the subclass wrap/patch/pad too hot for lbh 8hr products.There is no further action required.Based on this citi customizable search for the subclasses of wrap/patch/pad too hot for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of wrap/patch/pad too hot for lbh product.Site sample status: not received.Reasonably suggest device malfunction: no; severity of harm: n/a.Follow-up (01jun2017): follow-up attempts completed.No further information expected.Follow-up (17feb2020): new information received from a product quality complaint group includes: investigation results., comment: based on the information provided, the reported events burn blister and device issue as described in this case are considered serious bodily injuries/unanticipated serious deterioration requiring medical intervention to prevent permanent damage or impairment of body structure, 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: 6477450
• MDR Text Key: 72335067
• Report Number: 1066015-2017-00075
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention