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

Device Problem Temperature Problem (3022)

Patient Problems Skin Discoloration (2074); Burn, Thermal (2530)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] burned my skin, peeled off so you can see the white underneath [thermal burn] , burned my skin, peeled off so you can see the white underneath [skin exfoliation] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program, thermacare (b)(6) page.A contactable consumer reported a patient of unspecified age, ethnicity and gender started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2017, the patient reported using a back/hip heatwrap and when placed it on hip, one of the stones laid on the lower stomach burned the skin, peeled off so you can see the white underneath.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the events was unknown.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment based on the information provided, the events of thermal burn and skin exfoliation as described in this case are serious bodily injury potentially 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 events of thermal burn and skin exfoliation as described in this case are serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] burned my skin, peeled off so you can see the white underneath [thermal burn] , burned my skin, peeled off so you can see the white underneath [skin exfoliation] ,.Case narrative:this is a spontaneous report from a pfizer-sponsored program, thermacare facebook page.A contactable consumer reported a patient of unspecified age, ethnicity and gender started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2017, the patient reported using a back/hip heatwrap and when placed it on hip, one of the stones laid on the lower stomach burned the skin, peeled off so you can see the white underneath.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the events was unknown.Product investigation results are pending.Severity of harm and reasonably suggest device malfunction remain blank.Reporter comment: when i placed it on my hip, one of the stones laid on my lower stomach.To my surprised the stone burned my skin, peeled off so you can see the white underneath.No follow-up attempts are possible.No further information is expected.Follow-up ((b)(6) 2019): new information received from a product quality complaints group includes notification that the severity of harm and/or reasonably suggest device malfunction has not been set by the manufacturing site.Initial review and rationale in progress.Company clinical evaluation comment based on the information provided, the events of thermal burn and skin exfoliation as described in this case are serious bodily injury potentially 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 events of thermal burn and skin exfoliation as described in this case are serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] burned the skin, peeled off so you can see the white underneath [thermal burn] , burned the skin, peeled off so you can see the white underneath [skin exfoliation].Case narrative:this is a spontaneous report from a pfizer-sponsored program, thermacare facebook page.A contactable consumer reported a patient of unspecified age, and gender started to use thermacare heatwrap (thermacare lower back & hip) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On (b)(6) 2017, the patient reported using a back/hip heatwrap and when placed it on hip, one of the stones laid on the lower stomach burned the skin, peeled off so you can see the white underneath in (b)(6) 2017.Action taken in response to the event for thermacare heatwrap was unknown.Clinical outcome of the events was unknown.Severity of harm and reasonably suggest device malfunction remain blank.According to further information received from product quality group from manufacturing site: sub-class: adverse event safety request for investigation.Site sample status: not received.Rsnbly suggest device malfunc?: no.Severity of harm: n/a.Investigation findings:this investigation was conducted for an unknown lot number lower back/hip 8 hour product.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Follow-up (21oct2019): new information received from a product quality complaints group includes notification that the severity of harm and/or reasonably suggest device malfunction has not been set by the manufacturing site.Initial review and rationale in progress.Follow-up (21jan2020): new information received from product quality complaint group includes investigation results from manufacturing site.No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment based on the information provided, the events of thermal burn and skin exfoliation as described in this case are serious bodily injury potentially 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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.No further investigations or actions are suggested at this time.Comment: based on the information provided, the events of thermal burn and skin exfoliation as described in this case are serious bodily injury potentially 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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.No further investigations or actions are suggested at this time.

Manufacturer Narrative

Sub-class: adverse event safety request for investigation.Site sample status: not received.Rsnbly suggest device malfunc?: no.Severity of harm: n/a.Investigation findings:this investigation was conducted for an unknown lot number lower back/hip 8 hour product.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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.

• 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: 6282420
• MDR Text Key: 65997784
• Report Number: 1066015-2017-00012
• 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,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention