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

Lot Number DK2631

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Burnt with blisters [burns second degree], 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 lower back & hip) on an unknown date for lower back pain.Relevant medical history and concomitant medications were not provided.The patient purchased this product for lower back pain.It said it would last 16 hours and the patient wore it 6 hours.When removed it the patient was burnt with blisters.The patient went to two different doctors because it would not get better.The action taken with thermacare heatwrap in response to the event and the clinical outcome of the event 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].Burnt with blisters [burns second degree],.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 lower back & hip) device lot number: dk2631, expiry date: 31jan2023 on an unknown date for lower back pain.Relevant medical history and concomitant medications were not provided.The patient purchased this product for lower back pain.It said it would last 16 hours and the patient wore it 6 hours.Upon removal, the patient was burnt with blisters.The patient went to two different doctors because it would not get better.Action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Additional information received from product quality complaint (pqc) group included investigation results.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 stated "i was burnt with blisters" the cause of the consumer complaint of "i was burnt with blisters" is inconclusive since review of product history 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 avoid risks of burn blisters.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, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.Follow-up(28jan2021): follow-up attempts are completed.No further information is expected.Follow-up (02feb2021): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (25feb2021): new information received from product quality complaints (pqc) group included: device lot number and expiry date added, updated product quality investigation results.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).After a review of the batch thermal records, thermal results all met product release criteria.Consumer stated "i was burnt with blisters" the cause of the consumer complaint of "i was burnt with blisters" is inconclusive since review of product history 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 avoid risks of burn blisters.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, an inspection of retained samples.Retained samples met the product description, and the product is within the expiration date.This complaint does not impact the product quality for the batch.

Event Description

Event verbatim [preferred term] burnt with blisters [burns second degree], , 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 lower back & hip) on an unknown date for lower back pain.Relevant medical history and concomitant medications were not provided.The patient purchased this product for lower back pain.It said it would last 16 hours and the patient wore it 6 hours.Upon removal, the patient was burnt with blisters.The patient went to two different doctors because it would not get better.Action taken with thermacare heatwrap in response to the event and the clinical outcome of the event were unknown at the time of the report.Additional information received from product quality complaint (pqc) group included investigation results.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 or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.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.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 packaged product.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Return sample evaluation: a return sample has not been received at the site for evaluation as of 29jan2021.Follow-up(28jan2021): follow-up attempts are completed.No further information is expected.Follow-up (02feb2021): new information received from product quality complaints (pqc) group included: product quality investigation results.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 or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.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.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 packaged product.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Return sample evaluation: a return sample has not been received at the site for evaluation as of 29jan2021.

• 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: 11245943
• MDR Text Key: 229296324
• Report Number: 1066015-2021-00014
• 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: 01/16/2021

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: 01/31/2023
• Device Lot Number: DK2631
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/17/2021; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention