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

Lot Number X76048

Device Problems Use of Device Problem (1670); Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)

Patient Problems Abrasion (1689); Pain (1994); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

It was so difficult to detach the wrap, that the skin was peeled off with it/that was very painful [skin abrasion], it was so difficult to detach the wrap/the heat wrap had no adhesive surface at all [device issue].Case narrative: this is a spontaneous report from the pfizer-sponsored program brand websites for division consumer healthcare (b)(6) from a contactable consumer (patient).A (b)(6) old male patient started to use thermacare heatwrap (thermacare lower back & hip) lot#: x76048, expiration date 30jun2021, on an unknown date for an unknown indication.Relevant medical history and concomitant medications were none.The patient bought the heatwrap in the pharmacy.He put it on him, at the beginning the warmth was very enjoyable.When he removed it after 6 hours, it was so difficult to detach the wrap, that the skin was peeled off with it.That was very painful.The patient confirmed that when removing the heat wrap, the skin on the adhesive surface has also been removed.But the heat wrap had no adhesive surface at all.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.Company clinical evaluation comment: based on the information provided, the events of "skin was peeled off with it/painful" and "so difficult to detach the wrap/heat wrap had no adhesive surface at all" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "skin was peeled off with it/painful" and "so difficult to detach the wrap/heat wrap had no adhesive surface at all" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] it was so difficult to detach the wrap, that the skin was peeled off with it/that was very painful [skin abrasion] , it was so difficult to detach the wrap/the heat wrap had no adhesive surface at all [device adhesion issue].Case narrative:this is a spontaneous report from the pfizer-sponsored program brand websites for division consumer healthcare germany from a contactable consumer (patient).A 34-year-old male patient started to use thermacare heatwrap (thermacare lower back & hip) lot# x76048, expiration date 30jun2021, on an unknown date for an unknown indication.Relevant medical history and concomitant medications were none.The patient bought the heatwrap in the pharmacy.When he put it on, at the beginning, the warmth was very enjoyable.When he removed it after 6 hours, it was so difficult to detach the wrap, that the skin was peeled off with it.That was very painful.The patient confirmed that when removing the heat wrap, the skin on the adhesive surface has also been removed.But the heat wrap had no adhesive surface at all.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.Per the product quality group, the severity of harm has been assessed as s3.Site conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wrap caused the "skin to peel off." the cause of the consumer stating the wraps peeled his skin off is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to any avoid the risks.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (05dec2019): new information received from product quality group included: assessment of severity of harm.Follow-up (09dec2019): new information received from product quality group included: investigation results., comment: based on the information provided, the events of "skin was peeled off with it/painful" and "so difficult to detach the wrap/heat wrap had no adhesive surface at all" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wrap caused the "skin to peel off." the cause of the consumer stating the wraps peeled his skin off is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to any avoid the risks.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Event verbatim [preferred term] it was so difficult to detach the wrap, that the skin was peeled off with it/that was very painful [skin abrasion] , it was so difficult to detach the wrap/the heat wrap had no adhesive surface at all [device issue].Case narrative:this is a spontaneous report from the pfizer-sponsored program brand websites for division consumer healthcare germany from a contactable consumer (patient).A 34-year-old male patient started to use thermacare heatwrap (thermacare lower back & hip) lot# x76048, expiration date 30jun2021, on an unknown date for an unknown indication.Relevant medical history and concomitant medications were none.The patient bought the heatwrap in the pharmacy.When he put it on, at the beginning, the warmth was very enjoyable.When he removed it after 6 hours, it was so difficult to detach the wrap, that the skin was peeled off with it.That was very painful.The patient confirmed that when removing the heat wrap, the skin on the adhesive surface has also been removed.But the heat wrap had no adhesive surface at all.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.Per the product quality group, the severity of harm has been assessed as s3.Additional information has been requested and will be provided as it becomes available.Follow-up (05dec2019): new information received from product quality group included: assessment of severity of harm.Company clinical evaluation comment: based on the information provided, the events of "skin was peeled off with it/painful" and "so difficult to detach the wrap/heat wrap had no adhesive surface at all" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "skin was peeled off with it/painful" and "so difficult to detach the wrap/heat wrap had no adhesive surface at all" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wrap caused the "skin to peel off." the cause of the consumer stating the wraps peeled his skin off is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to any avoid the risks.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Exped trend assmt.& rationale: 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: 12/05/2016 through 12/05/2019/manufacturing site: pfizer albany/complaint class: external cause investigation complaint subclass: adverse event/severe/unknown.The citi customizable search returned a total of 125 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown.The subclass shows a seasonality increase in april 2019.A change in safety¿s procedure that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline and an overall increase of subsequent complaints received at the site.The data shows a spike of complaints received in may 2019.Twenty of the 48 complaints received were related to burns, blisters, and redness; twenty-eight has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Seven of the12 complaints received in june 2019 were related burns, blister, and redness; five has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Eight of the 14 complaints received in july 2019 were related burns, blister, and redness; six has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Complaints with a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr are investigated attaching memo cd-66388 effective 09-dec-2019.April 2019 through july of 2019 shows an increase attributed to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473, and w37940 from april 2019.According to rpt-38832, hazard analysis, thermacare heat wrap product: 8 and 12hr, effective 30-apr-2020, section 10.1 - market actions (recall), effective date: 30-apr-2020, in april 2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower back, and hip include s97473 (us), s00639 (germany/switzerland), s23902 (uk/ireland), and w37940 (germany/switzerland).The recall action taken after the batches were released with an out of specification result for high-temperature cell(s), and no product isolation of impacted product performed.The release of these batches without product isolation is a compliance gap.The manufacturing investigation ((b)(4), closed 04-sep-2019) resulted in corrective actions, including improving procedures for containing and investigating the nonconforming.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 36 month trend chart attached lbh ae serious unknown 05-dec-2016 to 05-dec-2019.

Event Description

Event verbatim [preferred term]: it was so difficult to detach the wrap, that the skin was peeled off with it/that was very painful [skin abrasion], it was so difficult to detach the wrap/the heat wrap had no adhesive surface at all [device adhesion issue], narrative: this is a spontaneous report from the pfizer-sponsored program brand websites for devision consumer healthcare germany from a contactable consumer (patient).A 34-year-old male patient started to use thermacare heatwrap (thermacare lower back & hip) lot# x76048, expiration date 30jun2021, on an unknown date for an unknown indication.Relevant medical history and concomitant medications were none.The patient bought the heatwrap in the pharmacy.When he put it on, at the beginning, the warmth was very enjoyable.When he removed it after 6 hours, it was so difficult to detach the wrap, that the skin was peeled off with it.That was very painful.The patient confirmed that when removing the heat wrap, the skin on the adhesive surface has also been removed.But the heat wrap had no adhesive surface at all.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.Per the product quality group, the severity of harm has been assessed as s3.Site conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports wrap caused the "skin to peel off." the cause of the consumer stating the wraps peeled his skin off is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device, following all safety and use information as provided with the wrap to any avoid the risks.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Exped trend assmt.& rationale: 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: 12/05/2016 through 12/05/2019/manufacturing site: pfizer albany/complaint class: external cause investigation complaint subclass: adverse event/severe/unknown.The citi customizable search returned a total of 125 complaints for lower back and hip (lbh) products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown.The subclass shows a seasonality increase in april 2019.A change in safety's procedure that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline and an overall increase of subsequent complaints received at the site.The data shows a spike of complaints received in may 2019.Twenty of the 48 complaints received were related to burns, blisters, and redness; twenty-eight has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Seven of the12 complaints received in june 2019 were related burns, blister, and redness; five has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Eight of the 14 complaints received in july 2019 were related burns, blister, and redness; six has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Complaints with a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr are investigated attaching memo cd-66388 effective 09-dec-2019.April 2019 through july of 2019 shows an increase attributed to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473, and w37940 from april 2019.According to rpt-38832, hazard analysis, thermacare heat wrap product: 8 and 12hr, effective 30-apr-2020, section 10.1 - market actions (recall), effective date: 30-apr-2020, in april 2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower back, and hip include s97473 (us), s00639 (germany/switzerland), s23902 (uk/ireland), and w37940 (germany/switzerland).The recall action taken after the batches were released with an out of specification result for high-temperature cell(s), and no product isolation of impacted product performed.The release of these batches without product isolation is a compliance gap.The manufacturing investigation (pr 3938189, closed 04-sep-2019) resulted in corrective actions, including improving procedures for containing and investigating the nonconforming.Exped trend actions taken: based on this citi customizable search, there is not a trend identified for the subclass of adverse event/serious/unknown.Refer to the attached 36 month trend chart attached lbh ae serious unknown 05-dec-2016 to 05-dec-2019.Follow-up (05dec2019): new information received from product quality group included: assessment of severity of harm.Follow-up (09dec2019): new information received from product quality group included: investigation results.Follow-up (17jan2020): follow-up attempts completed.No further information expected.Follow-up (08oct2020): new information received from product quality complaint group includes: correction to investigation results (added lot trend assessment).Follow-up attempts completed.No further information expected., comment: based on the information provided, the events of "skin was peeled off with it/painful" and "so difficult to detach the wrap/heat wrap had no adhesive surface at all" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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: 9417661
• MDR Text Key: 187270881
• Report Number: 1066015-2019-00517
• 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,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/25/2019

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: 06/30/2021
• Device Lot Number: X76048
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/12/2019; 12/23/2019; 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR