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

Lot Number AD3823

Device Problems Nonstandard Device (1420); Overheating of Device (1437); Excessive Heating (4030)

Patient Problem Burn, Thermal (2530)

Event Date 02/01/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] received a burn on her back/minor burn on her back [thermal burn], received a notice about the recall on thermacare lower back and hip/felt like they were hotter [device issue].Case narrative:this is a spontaneous report from a contactable physician reporting for herself.A (b)(6)-year-old female patient (b)(6) started to use thermacare heatwrap (thermacare lower back & hip), device lot number ad3823, expiration date aug2021, ndc number: (b)(4), via an unspecified route of administration from an unspecified date "for at least 4 years" for back pain which "uses only when traveling or having really bad back pain, episodic use".The patient medical history and concomitant medications were none.Patient received a notice about the recall on thermacare lower back and hip l/xl.Patient used the upc to confirm that the boxes she had were the defected ones.Both boxes have the same upc, lot, and expiration date as documented.The patient also reported that she experienced a minor burn on her back in (b)(6) 2019.Patient used them in (b)(6) 2019 after a flight and that is when she had the burn.She used them when flying back and forth to (city name), it helps with her back issues.It was reported that when she put them on it felt like they were hotter, and she did get a burn.For that particular trip when she had the burn, she used maybe a total of 3 in one week.The physician she was seeing at that time happened to notice it.It lasted for about week.Her doctor told her to put some bacitracin on it.No investigations were performed.Patient had 2 packages of 2 heat wraps and then one that is not in a box, for a total of 5 to return.The action taken with thermacare heatwrap was dose not changed.The event minor burn on her back was recovered completely in (b)(6) 2019.The reporting physician assessed the event "minor burn on her back" as non-serious and related to thermacare heatrwap.Additional information has been requested and will be provided as it becomes available.Follow-up (20may2019): new information reported from a contactable physician includes: patient's age (patient self), height and weight, action taken, ndc, event detail "minor burn on her back", date, outcome, indication, duration, and product use frequency, assessment (seriousness, and causality), no concomitant medications, no medical history, no investigations, sample availability, treatment information, details on the date of the event (flying back and forth to a city), and additional events "received a notice about the recall on thermacare lower back and hip/felt like they were hotter".Company clinical evaluation comment: based on the information provided, the events of "felt like they were hotter, and she did get a burn" as described are considered serious bodily injury 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 "felt like they were hotter, and she did get a burn" as described are considered serious bodily injury 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

Site sample was not received.Batch ad3823 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports that, " received a burn on her back/minor burn on her back." 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 avoid the risks of burns or other skin irritations.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 11th complaint for the sub class adverse event safety request for investigation received at the (site name withheld) site requiring an evaluation for this batch.The previous investigations were not confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist for this lot.

Event Description

Event verbatim [preferred term] received a burn on her back/minor burn on her back [thermal burn], received a notice about the recall on thermacare lower back and hip/felt like they were hotter [device issue].Narrative: this is a spontaneous report from a contactable physician reporting for herself.A 66-year-old female patient (height: 165 cm or 5 feet, 5 inches, weight: 58.97 kg or 130 pounds) started to use thermacare heatwrap (thermacare lower back & hip), device lot number ad3823, expiration date aug2021, ndc number: 0573301003, via an unspecified route of administration from an unspecified date "for at least 4 years" for back pain which "uses only when traveling or having really bad back pain, episodic use." the patient medical history and concomitant medications were none.Patient received a notice about the recall on thermacare lower back and hip l/xl.Patient used the upc to confirm that the boxes she had were the defected ones.Both boxes have the same upc, lot, and expiration date as documented.The patient also reported that she experienced a minor burn on her back in (b)(6) 2019.Patient used them in (b)(6) 2019 after a flight and that is when she had the burn.She used them when flying back and forth to (city name), it helps with her back issues.It was reported that when she put them on it felt like they were hotter, and she did get a burn.For that particular trip when she had the burn, she used maybe a total of 3 in one week.The physician she was seeing at that time happened to notice it.It lasted for about week.Her doctor told her to put some bacitracin on it.No investigations were performed.Patient had 2 packages of 2 heat wraps and then one that is not in a box, for a total of 5 to return.The action taken with thermacare heatwrap was dose not changed.The event minor burn on her back was recovered completely in (b)(6) 2019.The reporting physician assessed the event "minor burn on her back" as non-serious and related to thermacare heatwrap.According to product complaint group: site sample was not received.Batch ad3823 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports that, " received a burn on her back/minor burn on her back." 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 avoid the risks of burns or other skin irritations.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 11th complaint for the sub class adverse event safety request for investigation received at the (site name withheld) site requiring an evaluation for this batch.The previous investigations were not confirmed to have a manufacturing root cause related to the subclass.On the basis of this evaluation, a trend does not exist for this lot.Follow-up (20may2019): new information reported from a contactable physician includes: patient's age (patient self), height and weight, action taken, ndc, event detail "minor burn on her back", date, outcome, indication, duration, and product use frequency, assessment (seriousness, and causality), no concomitant medications, no medical history, no investigations, sample availability, treatment information, details on the date of the event (flying back and forth to a city), and additional events "received a notice about the recall on thermacare lower back and hip/felt like they were hotter." follow-up (18jul2019): follow-up attempts completed.No further information expected.Follow-up (08jul2020): new information received from product complaint group includes investigation results.Follow-up attempts are 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: 8663268
• MDR Text Key: 146927097
• Report Number: 1066015-2019-00177
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2021
• Device Lot Number: AD3823
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 59