MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAP; DISPOSABLE PACK, HOT

Device Problem Component Missing (2306)

Patient Problems Laceration(s) (1946); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Gave her a burn [thermal burn]; kind of pulled the skin up a little bit [laceration]; it looks like it was made differently, it does not have a sticking fibre on it, the protective pad [product quality issue].Case description: this is a spontaneous report from a non-contactable consumer.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare heatwrap), from an unspecified date to an unspecified date at an unknown frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.Past product history included thermacare heatwrap (thermacare heatwrap) with no adverse effect.The patient reported it gave her a burn and kind of pulled the skin up a little bit.She had used them for years and that had never happened before but it looks like it was made differently, it does not have a sticking fiber on it, the protective pad on an unspecified date with outcome of unknown.The action taken with thermacare heatwrap was unknown.No follow-up attempts are possible.An investigation of the device could not be conducted.Company clinical evaluation comment: based on the information provided, the event of 'burn and kind of pulled the skin up a little bit' and the associated product complaint as described in this case are considered 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.This case meets initial and final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event of 'burn and kind of pulled the skin up a little bit' and the associated product complaint as described in this case are considered 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.This case meets initial and final 10-day eu and 30-day fda reportability.

Manufacturer Narrative

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/serious/unknown.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.Reasonably suggest device malfunction: no.Site sample status: not received.

Event Description

Event verbatim [preferred term] gave her a burn [thermal burn] , kind of pulled the skin up a little bit [skin laceration] , it looks like it was made differently, it does not have a sticking fibre on it, the protective pad [product quality issue].Case narrative:this is a spontaneous report from a non-contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwrap), from an unspecified date to an unspecified date at an unknown frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.Past product history included thermacare heatwrap (thermacare heatwrap) with no adverse effect.The patient reported it gave her a burn and kind of pulled the skin up a little bit.She had used them for years and that had never happened before but it looks like it was made differently, it does not have a sticking fiber on it, the protective pad on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.Product investigation results are as follows: 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/serious/unknown.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.Reasonably suggest device malfunction: no.Site sample status: not received.No follow-up attempts are possible.An investigation of the device could not be conducted.Follow-up (20mar2020): new information received from a product quality complaint group includes product investigation results.No follow-up attempts are possible.No further information is expected.Comment: based on the information provided, the event of 'burn and kind of pulled the skin up a little bit' and the associated product complaint as described in this case are considered 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.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] gave her a burn [thermal burn] , kind of pulled the skin up a little bit [skin laceration] , it looks like it was made differently, it does not have a sticking fibre on it, the protective pad [product quality issue].Case narrative:this is a spontaneous report from a non-contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare heatwrap), from an unspecified date to an unspecified date at an unknown frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.Past product history included thermacare heatwrap (thermacare heatwrap) with no adverse effect.The patient reported it gave her a burn and kind of pulled the skin up a little bit.She had used them for years and that had never happened before but it looks like it was made differently, it does not have a sticking fiber on it, the protective pad on an unspecified date.The action taken with thermacare heatwrap was unknown.The outcome of the events was unknown.Product investigation results are as follows: 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/serious/unknown.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.Reasonably suggest device malfunction: no.Site sample status: not received.No follow-up attempts are possible.An investigation of the device could not be conducted.Follow-up (23mar2020): new information received from a product quality complaint group includes product investigation results.No follow-up attempts are possible.No further information is expected.Amendment: this follow-up is being submitted to amend previously reported information: product problem added and updated follow-up date in narrative.Comment: based on the information provided, the event of 'burn and kind of pulled the skin up a little bit' and the associated product complaint as described in this case are considered 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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

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/serious/unknown.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.Reasonably suggest device malfunction: no.Site sample status: not received.

• Brand Name: THERMACARE HEATWRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 5472389
• MDR Text Key: 39426584
• Report Number: 1066015-2016-00033
• 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: 02/01/2016

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: 02/01/2016
• Initial Date FDA Received: 03/01/2016
• Supplement Dates Manufacturer Received: 02/01/2016; 02/01/2016
• Supplement Dates FDA Received: 04/08/2020; 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention