MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT

Device Problems Insufficient Heating (1287); Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Event verbatim: the friend reports she always used them for her neck pain and sometimes they get so hot she had to take them off.[device issue], narrative: this is a spontaneous report from a contactable consumer reported for friend.A (b)(6)- year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for neck pain.Medical history and concomitant medications were not reported.The patient always used thermacare advanced muscle pain therapy heat wrap for her neck pain and sometimes they got so hot she had to take them off.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.

Event Description

Event verbatim [preferred term]: the friend reports she always used them for her neck pain and sometimes they get so hot she had to take them off.[device issue].[narrative: this is a spontaneous report from a contactable consumer reported for friend.A 38 year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for neck pain.Medical history and concomitant medications were not reported.The patient always used thermacare advanced muscle pain therapy heat wrap for her neck pain and sometimes they got so hot she had to take them off.The reporter further stated her friend said it and the statement she made was they used to get hot, but not anymore.These barely got warm.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.Follow-up (13nov2020): new information received from query response via product complaint group included: new complaint (these barely got warm).

Event Description

The friend reports she always used them for her neck pain and sometimes they get so hot she had to take them off.[device issue].Narrative: this is a spontaneous report from a contactable consumer reported for friend.A 38 year-old female patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) from an unspecified date for neck pain.Medical history and concomitant medications were not reported.The patient always used thermacare advanced muscle pain therapy heat wrap for her neck pain and sometimes they got so hot she had to take them off.The reporter further stated her friend said it and the statement she made was they used to get hot, but not anymore.These barely got warm.The action taken in response to the event for the product was unknown.The outcome of the event was unknown.On 18nov2020, the product quality complaint group provided the following investigation results from the manufacturing site that yielded no product quality issues.Product: thermacare heatwraps multi-purpose muscle pain.Device lot number: unknown.Expiration date: unknown.Description of compliant: "sometimes they got so hot she had to take them off".Complaint subclass: wrap / patch / pad too hot.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Summary of investigation: this investigation was conducted for an unknown lot number m&j product.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.Root cause / capa: process related?: no, final confirmation status: not confirmed, vendor related?: no, root cause category: non-assignable (complaint not confirmed).Expedite trend identified?: no.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.Follow-up (13nov2020): new information received from query response via product complaint group included: new complaint (these barely got warm).Follow-up (18nov2020): new information received from the product quality complaint group included: investigation results that yielded no product quality issues.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

Product: thermacare heatwraps multi-purpose muscle pain.Description of compliant: "sometimes they got so hot she had to take them off".Complaint subclass: wrap / patch / pad too hot.Reasonably suggest device malfunction: no.Severity of harm: n/a.Site sample status: not received.Summary of investigation: this investigation was conducted for an unknown lot number m&j product.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.Root cause / capa: process related?: no, final confirmation status: not confirmed, vendor related?: no, root cause category: non-assignable (complaint not confirmed).Expedite trend identified?: no.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.

Manufacturer Narrative

Product: thermacare heatwraps multi-purpose muscle pain.Device lot number: unknown.Expiration date: unknown.Description of compliant: "sometimes they got so hot she had to take them off".Complaint subclass: wrap/patch/pad too hot.Site sample status: not received.Summary of investigation: this investigation was conducted for an unknown lot number m&j product.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.Root cause/ capa: process related?: no, final confirmation status: not confirmed, vendor related?: no, root cause category: non-assignable (complaint not confirmed).Expedite trend identified?: no.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.

Event Description

Event verbatim [preferred term]: the friend reports she always used them for her neck pain and sometimes they get so hot she had to take them off.[device issue], narrative: this is a spontaneous report from a contactable consumer reported for friend.A 38-year-old female patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) from an unspecified date for neck pain.Medical history and concomitant medications were not reported.The patient always used thermacare advanced muscle pain therapy heat wrap for her neck pain and sometimes they got so hot she had to take them off.The reporter further stated her friend said it and the statement she made was they used to get hot, but not anymore.These barely got warm.The action taken in response to the event for the product was unknown.The outcome of the event was unknown.On 18nov2020, the product quality complaint group provided the following investigation results from the manufacturing site that yielded no product quality issues.Product: thermacare heatwraps multi-purpose muscle pain.Device lot number: unknown.Expiration date: unknown.Description of compliant: "sometimes they got so hot she had to take them off".Complaint subclass: wrap/patch/pad too hot.Site sample status: not received.Summary of investigation: this investigation was conducted for an unknown lot number m&j product.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.Root cause/ capa: process related?: no, final confirmation status: not confirmed, vendor related?: no, root cause category: non-assignable (complaint not confirmed).Expedite trend identified?: no.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.According to device complaint handling unit (dchu), severity of harm was assessed as s3.Reasonably suggested malfunction was yes.Follow-up (13nov2020): new information received from query response via product complaint group included: new complaint (these barely got warm).Follow-up (18nov2020): new information received from the product quality complaint group included: investigation results that yielded no product quality issues.Follow-up attempts are completed.No further information is expected.Follow-up (19jan2021): new information received from device complaint handling unit (dchu) included: severity of harm was assessed as s3.Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 10823151
• MDR Text Key: 219545585
• Report Number: 1066015-2020-00191
• 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,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/19/2020; 11/24/2020; 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 70