MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number DK2624

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Event Description

The sticky pack was so stuck on patient's skin, it took skin off [skin exfoliation], the sticky pack was so stuck on patient's skin, it took skin off [device adhesion issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A patient of an unknown age and gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number dk2624 and expiration date feb2023, on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not provided.The patient bought a pack of the wraps and the sticky pack was so stuck on patient's skin, it took skin off.The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term].The sticky pack was so stuck on patient's skin, it took skin off [skin exfoliation], the sticky pack was so stuck on patient's skin, it took skin off [device adhesion issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A patient of an unknown age and gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number "dk2624" and expiration date feb2023, on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not provided.The patient bought a pack of the wraps and the sticky pack was so stuck on patient's skin, it took skin off.The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.According to product quality complaints: a sample was not received at the site.There was no reasonable suggestion of device malfunction.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: (b)(6) 2017 through (b)(6) 2020.Manufacturing site: (site name) / complaint class: external cause investigation / complaint sub class: adverse event/negligible-minor for investigation: the citi search returned a total 7 complaints for the (nsw) 8hr products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event/negligible-minor for investigation.A citi complaint trend search was performed for the subclass adverse event/negligible-minor for investigation for (nsw) 8hr products.Based on this citi search, the data did not show an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/negligible-minor for investigation for (nsw) 8hr products, refer to the 36-month attached trend chart for adverse event (nsw) 8hr (b)(6) 2017 to (b)(6) 2020.There is no further action required.This investigation was conducted for an unknown lot number (nsw) 8hr 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 adverse event/negligible-minor 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.Follow-up (24sep2020): follow-up attempts completed.No further information expected.Follow-up (01oct2020): new information received from a product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

A sample was not received at the site.There was no reasonable suggestion of device malfunction.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: (b)(6) 2017 through (b)(6) 2020 manufacturing site: (site name) / complaint class: external cause investigation / complaint sub class: adverse event/negligible-minor for investigation: the citi search returned a total 7 complaints for the (nsw) 8hr products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event/negligible-minor for investigation.A citi complaint trend search was performed for the subclass adverse event/negligible-minor for investigation for (nsw) 8hr products.Based on this citi search, the data did not show an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/negligible-minor for investigation for (nsw) 8hr products, refer to the 36-month attached trend chart for adverse event (nsw) 8hr (b)(6) 2017 to (b)(6) 2020.There is no further action required.This investigation was conducted for an unknown lot number (nsw) 8hr 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 adverse event/negligible-minor 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.

Manufacturer Narrative

A sample was not received at the site.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: 15sep2017 through 15sep2020 manufacturing site: (site name) / complaint class: external cause investigation / complaint sub class: adverse event/negligible-minor for investigation: the citi search returned a total 7 complaints for the (nsw) 8hr products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event/negligible-minor for investigation.A citi complaint trend search was performed for the subclass adverse event/negligible-minor for investigation for (nsw) 8hr products.Based on this citi search, the data did not show an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/negligible-minor for investigation for (nsw) 8hr products, refer to the 36-month attached trend chart for adverse event (nsw) 8hr 15sep2017 to 15sep2020.There is no further action required.This investigation was conducted for an unknown lot number (nsw) 8hr 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 adverse event/negligible-minor 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.

Event Description

Event verbatim [preferred term] the sticky pack was so stuck on patient's skin, it took skin off [skin exfoliation], the sticky pack was so stuck on patient's skin, it took skin off [device adhesion issue], , narrative: this is a spontaneous report from a contactable consumer (patient).A patient of an unknown age and gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number "dk2624" and expiration date feb2023, on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not provided.The patient bought a pack of the wraps and the sticky pack was so stuck on patient's skin, it took skin off.The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.According to product quality complaints: a sample was not received at the site.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: date contacted: 15sep2017 through 15sep2020 manufacturing site: (site name) / complaint class: external cause investigation / complaint sub class: adverse event/negligible-minor for investigation: the citi search returned a total 7 complaints for the (nsw) 8hr products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event/negligible-minor for investigation.A citi complaint trend search was performed for the subclass adverse event/negligible-minor for investigation for (nsw) 8hr products.Based on this citi search, the data did not show an increase over time for 36-months.There is not a trend identified for the subclass of adverse event/negligible-minor for investigation for (nsw) 8hr products, refer to the 36-month attached trend chart for adverse event (nsw) 8hr 15sep2017 to 15sep2020.There is no further action required.This investigation was conducted for an unknown lot number (nsw) 8hr 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 adverse event/negligible-minor 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.According to device complaint handling unit (dchu), severity of harm was assessed as s3.Reasonably suggested malfunction was yes.Follow-up (24sep2020): follow-up attempts completed.No further information expected.Follow-up (01oct2020): new information received from a product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (04jan2021): 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.

Manufacturer Narrative

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.

Event Description

Event verbatim [preferred term].The sticky pack was so stuck on patient's skin, it took skin off [skin exfoliation], the sticky pack was so stuck on patient's skin, it took skin off [device adhesion issue].Narrative: this is a spontaneous report from a contactable consumer (patient).A patient of an unknown age and gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number "dk2624" and expiration date feb2023, on an unknown date for an unknown indication.Relevant medical history and concomitant medications were not provided.The patient bought a pack of the wraps and the sticky pack was so stuck on patient's skin, it took skin off.The action taken with thermacare heatwrap in response to the events and the clinical outcome of the events were unknown at the time of the report.According to product quality complaints: 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.According to device complaint handling unit (dchu), severity of harm was assessed as s3.Reasonably suggested malfunction was yes.Follow-up (24sep2020): follow-up attempts completed.No further information expected.Follow-up (01oct2020): new information received from a product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (04jan2021): 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.Follow-up (26jan2021): new information received from a product quality complaint group includes revised investigation results for the correct sub class adverse event/serious/unknown.Follow-up attempts are completed.No further information is expected.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 10582986
• MDR Text Key: 208500910
• Report Number: 1066015-2020-00168
• 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: 09/15/2020

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
• Device Expiration Date: 02/01/2023
• Device Lot Number: DK2624
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/14/2020; 01/08/2021; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention