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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFIZER, INC. THERMACARE HEATWRAP; DISPOSABLE PACK, HOT
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PFIZER, INC. THERMACARE HEATWRAP; DISPOSABLE PACK, HOT Back to Search Results
Device Problems Overheating of Device (1437); Excessive Heating (4030)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
Actually get so hot, like i said, they will burn you [device issue].Case narrative: this is a spontaneous report from a contactable consumer.A currently (b)(6) female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number and expiration date unknown, from an unspecified date for her back.Medical history included arthritis.Concomitant medication includes unspecified blood pressure pills.The patient reported that the "thermacare heatwraps i have used these for years, never ever had a problem, i mean, they were always been really nice and hot, and they helped my back actually get so hot, like i said, they will burn you.And i know this because i've used them for years." the action taken with thermacare heatwrap and the outcome of the event was not reported.Company clinical evaluation comment: based on the available information, the complaint of "they get so hot they will burn you" as described is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.Comment: based on the available information, the complaint of "they get so hot they will burn you" as described is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.
 
Manufacturer Narrative
This investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 wrap/patch/pad too hot.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.The sample had not been received by the site.
 
Event Description
Actually get so hot, like i said, they will burn you [device issue].Case narrative: this is a spontaneous report from a contactable consumer reporting for herself.A currently 74-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number and expiration date unknown, from an unspecified date for her back.Medical history included arthritis and ongoing blood pressure problem.Concomitant medication includes unspecified blood pressure pills.The patient reported that the "thermacare heatwraps i have used these for years, never ever had a problem, i mean, they were always been really nice and hot, and they helped my back actually get so hot, like i said, they will burn you.And i know this because i've used them for years." the action taken with thermacare heatwrap and the outcome of the event was unknown.According to product quality complaint group: this investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 wrap/patch/pad too hot.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.The sample had not been received by the site.Severity of harm was provided as s3.Amendment: this follow-up report is being submitted to amend previously reported information: adverse event was unticked for medwatch report type.Follow-up (05feb2020): new information received from a product quality complaint group included: investigation results.Follow-up (20mar2020): new information received from product quality complaint included: severity ranking assessment.Follow-up attempts are completed.No further information is expected., comment: based on the available information, the complaint of "they get so hot they will burn you" as described is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.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.
 
Event Description
Event verbatim [preferred term]: actually get so hot, like i said, they will burn you [device issue].Case narrative:this is a spontaneous report from a contactable consumer.A currently 74-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number and expiration date unknown, from an unspecified date for her back.Medical history included arthritis and blood pressure problem.Concomitant medication includes unspecified blood pressure pills.The patient reported that the "thermacare heatwraps i have used these for years, never ever had a problem, i mean, they were always been really nice and hot, and they helped my back actually get so hot, like i said, they will burn you.And i know this because i've used them for years." the action taken with thermacare heatwrap and the outcome of the event was not reported.Amendment: this follow-up report is being submitted to amend previously reported information: adverse event was unticked for medwatch report type.Company clinical evaluation comment: based on the available information, the complaint of "they get so hot they will burn you" as described is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out., comment: based on the available information, the complaint of "they get so hot they will burn you" as described is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.
 
Manufacturer Narrative
This investigation was conducted for an unknown lot number lower back/hip (lbh) 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 wrap/patch/pad too hot.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.The sample had not been received by the site.
 
Event Description
Event verbatim [preferred term] actually get so hot, like i said, they will burn you [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer reporting for herself.A currently 74-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number and expiration date unknown, from an unspecified date for her back.Medical history included arthritis and blood pressure problem.Concomitant medication includes unspecified blood pressure pills.The patient reported that the "thermacare heatwraps i have used these for years, never ever had a problem, i mean, they were always been really nice and hot, and they helped my back actually get so hot, like i said, they will burn you.And i know this because i've used them for years." the action taken with thermacare heatwrap and the outcome of the event was not reported.According to product quality complaint group: summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 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 wrap/patch/pad too hot.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.The sample had not been received by the site.Amendment: this follow-up report is being submitted to amend previously reported information: adverse event was unticked for medwatch report type.Follow-up (05feb2020): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: based on the available information, the complaint of "they get so hot they will burn you" as described is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.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 available information, the complaint of "they get so hot they will burn you" as described is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.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
This investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 wrap/patch/pad too hot.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.The sample had not been received by the site.
 
Event Description
Event verbatim [preferred term].Actually get so hot, like i said, they will burn you [device issue].Narrative: this is a spontaneous report from a contactable consumer reporting for herself and from another contactable consumer.A currently 74-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number and expiration date unknown, from an unspecified date for her back.Medical history included arthritis and ongoing blood pressure problem.Concomitant medication includes unspecified blood pressure pills.The patient reported that the "thermacare heatwraps i have used these for years, never ever had a problem, i mean, they were always been really nice and hot, and they helped my back actually get so hot, like i said, they will burn you.And i know this because i've used them for years." the action taken with thermacare heatwrap and the outcome of the event was unknown.According to product quality complaint group: this investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 wrap/patch/pad too hot.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.The sample had not been received by the site.Severity of harm was provided as s3.Amendment: this follow-up report is being submitted to amend previously reported information: adverse event was unticked for medwatch report type.Follow-up (05feb2020): new information received from a product quality complaint group included: investigation results.Follow-up (20mar2020): new information received from product quality complaint included: severity ranking assessment.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: the person operating or using the suspect medical device on the patient at the time of the event updated as lay user., comment: based on the available information, the complaint of "they get so hot they will burn you" as described is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.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
This investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 wrap/patch/pad too hot.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.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.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.The sample had not been received by the site.
 
Event Description
Actually get so hot, like i said, they will burn you [device issue], narrative: this is a spontaneous report from a contactable consumer reporting for herself and from another contactable consumer.A currently 74-year-old female patient started to receive thermacare heatwrap (thermacare heatwrap), device lot number and expiration date unknown, from an unspecified date for her back.Medical history included arthritis and ongoing blood pressure problem.Concomitant medication includes unspecified blood pressure pills.The patient reported that the "thermacare heatwraps i have used these for years, never ever had a problem, i mean, they were always been really nice and hot, and they helped my back actually get so hot, like i said, they will burn you.And i know this because i've used them for years." the action taken with thermacare heatwrap and the outcome of the event was unknown.According to product quality complaint group: this investigation was conducted for an unknown lot number lower back/hip (lbh) product.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 wrap/patch/pad too hot.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.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.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.The sample had not been received by the site.Severity of harm was provided as s3.Amendment: this follow-up report is being submitted to amend previously reported information: adverse event was unticked for medwatch report type.Follow-up (05feb2020): new information received from a product quality complaint group included: investigation results.Follow-up (20mar2020): new information received from product quality complaint included: severity ranking assessment.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: the person operating or using the suspect medical device on the patient at the time of the event updated as lay user.Amendment: this follow-up report is being submitted to amend previously reported information: exped trend was added., comment: based on the available information, the complaint of "they get so hot they will burn you" as described is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.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.
 
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Brand Name
THERMACARE HEATWRAP
Type of Device
DISPOSABLE PACK, HOT
Manufacturer (Section D)
PFIZER, INC.
235 east 42 street
new york NY 10017
MDR Report Key9637282
MDR Text Key189167338
Report Number1066015-2020-00023
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
PMA/PMN Number
K953442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/06/2020
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 Received01/28/2020
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received02/07/2020
02/14/2020
04/03/2020
04/29/2020
11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight73
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