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

Lot Number CW8016

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Hypersensitivity/Allergic reaction (1907); Burn, Thermal (2530); Contact Dermatitis (4546)

Event Type  Injury  

Event Description

Event verbatim [preferred term] does not tolerate the product, she feels a burn on the skin/burning sensation [thermal burn], she might be allergic to the adhesive [dermatitis contact], she might be allergic to the adhesive [device material issue], , narrative: this is a spontaneous report from a contactable pharmacist based on information received by pfizer from angelini (at4662), license party for thermacare heatwrap.An approximate 42-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number cw8016, via an unspecified route of administration from an unspecified date at unknown dosage for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient did not tolerate the product, she felt a burn on the skin.Burning sensation was not due to generation of heat but the patient said she thought she might be allergic to the adhesive.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.

Event Description

Event verbatim [preferred term].Does not tolerate the product, she feels a burn on the skin/burning sensation [thermal burn], she might be allergic to the adhesive [dermatitis contact], she might be allergic to the adhesive [device material issue], , narrative: this is a spontaneous report from a contactable pharmacist based on information received by pfizer from (b)(6) (b)(4), for thermacare heatwrap.An approximate 42-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number cw8016) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient did not tolerate the product, she felt a burn on the skin.Burning sensation was not due to generation of heat but the patient said she thought she might be allergic to the adhesive.The heatwrap that caused the potential side effects was not available.Action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (04jan2021): new information received from (b)(6), (b)(4) for thermacare heatwrap includes: the heatwrap that caused the adverse events was not available.

Manufacturer Narrative

Batch cw8016 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), and trending were evaluated.No quality issues were identified.Trending information: an evaluation of the complaint history confirms that this is the first complaint about the subclass adverse event/serious/unknown received at the site requiring an evaluation for this batch.The citi customizable search returned a total of (b)(4) complaints about lower back/hip (lbh) products during this period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown.The subclass shows a seasonality increase in (b)(6) 2019 and (b)(6) 2019 through march 2020.The data shows an increase in complaints from (b)(6) 2019 and (b)(6) 2019.(b)(4) complaints received in april 2019 are related to burns, redness, blisters, irritation, and wrap too hot.The data shows a spike of complaints received in may 2019.(b)(4) complaints received are related to burns, blisters, and redness.Twenty three has a severity ranking of s1 too cool, heat/cold did not last long enough, never worked.The data shows a decrease in complaints beginning in (b)(6) 2019 about the subclass adverse event/serious/unknown.No trend identified in the lot or subclass.(b)(6) 2019 and (b)(6) 2019 shows an increase attributed to consumers reporting adverse events after being notified of a product recall.Based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown.In 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 a felt a burn on the skin.The cause of the consumer stated felt a burn on the skin 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.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.Reasonably suggest device malfunction was reported as no.Severity of harm was reported as n/a site sample status: not received.

Event Description

Event verbatim [preferred term].Does not tolerate the product, she feels a burn on the skin/burning sensation [thermal burn], she might be allergic to the adhesive [dermatitis contact], she might be allergic to the adhesive [device material issue].Narrative: this is a spontaneous report from a contactable pharmacist based on information received by pfizer from (b)(6) (at4662), license party (lp) for thermacare heatwrap.An approximately 42-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number cw8016, expiration date: dec2022, date of manufacture: 10jan2020 to 11jan2020) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient did not tolerate the product, she felt a burn on the skin.Burning sensation was not due to generation of heat but the patient said she thought she might be allergic to the adhesive.The heatwrap that caused the potential side effects was not available.Action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was unknown.According to the product quality control group for thermacare lower back/hip heat wrap 8 hr: batch cw8016 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), and trending were evaluated.No quality issues were identified.Trending information: an evaluation of the complaint history confirms that this is the first complaint about the subclass adverse event/serious/unknown received at the site requiring an evaluation for this batch.The citi customizable search returned a total of (b)(4) complaints about lower back/hip (lbh) products during this period for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown.The subclass shows a seasonality increase in (b)(6) 2019 and (b)(6) 2019 through (b)(6) 2020.The data shows an increase in complaints from (b)(6) 2019 and (b)(6) 2019.(b)(4) complaints received in april 2019 are related to burns, redness, blisters, irritation, and wrap too hot.The data shows a spike of complaints received in may 2019.(b)(4) complaints received are related to burns, blisters, and redness.(b)(4) has a severity ranking of s1 too cool, heat/cold did not last long enough, never worked.The data shows a decrease in complaints beginning in june 2019 about the subclass adverse event/serious/unknown.No trend identified in the lot or subclass.(b)(6) 2019 and (b)(6) 2019 shows an increase attributed to consumers reporting adverse events after being notified of a product recall.Based on this citi search, there is not a trend identified for the subclass of adverse event/serious/unknown.In 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 a felt a burn on the skin.The cause of the consumer stated felt a burn on the skin 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.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.Reasonably suggest device malfunction was reported as no.Severity of harm was reported as n/a site sample status: not received.Follow-up (04jan2021): new information received from angelini, lp for thermacare heatwrap includes: the heatwrap that caused the adverse events was not available.Follow (11jan2021): new information from product complaints group included: investigation results.Follow up attempts completed.No further information is expected.

• 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: 11108593
• MDR Text Key: 224835560
• Report Number: 1066015-2021-00002
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2020

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: 12/01/2022
• Device Lot Number: CW8016
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2021; 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR