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

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

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 01/30/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] i had a burn place on my back/which was very raw and red [thermal burn].Narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), via an unspecified route of administration from (b)(6) 2021 for approximately 7 hours for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient had frequently worn these heat wraps over many years and had no issues with them.On saturday, (b)(6) 2021, the patient put on one of the heatwraps around the waist.The patient wore it properly and adhered the instructions on the package.Patient had a tank top underneath the heatwrap so it would not be directly touching his/her back.The patient had the heatwrap on for approximately 7 hours.When he/she took the heatwrap off on that evening ((b)(6)2021), he/she had a burn place on his/her back, of which was very raw and red.It had now been a week later and the patient still have the burned place on his/her back.The patient was requesting that you acknowledge this incident and handle it properly.The patient had attached some pictures as proof of what happened.The action taken in response to the event was unknown.The outcome of the event was not recovered.Additional information has been requested and will be provided as it becomes available.

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.Evaluation of attached affiliate photo does not provide evidence to support a defective product.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Site sample status: photos received.

Event Description

Event verbatim [preferred term]: i had a burn place on my back/which was very raw and red [thermal burn].Narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to use thermacare heatwrap (thermacare lower back & hip), from (b)(6) 2021 for approximately 7 hours for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient had frequently worn these heatwraps over many years and had no issues with them.On saturday, (b)(6) 2021, the patient put on one of the heatwraps around the waist.The patient wore it properly and adhered to the instructions on the package.The patient had a tank top underneath the heatwrap so it would not be directly touching his/her back.The patient had the heatwrap on for approximately 7 hours.When he/she took the heatwrap off on that evening ((b)(6) 2021), he/she had a burn place on his/her back, of which was very raw and red.It had now been a week later and the patient still had the burned place on his/her back.The patient was requesting that you acknowledge this incident and handle it properly.The patient had attached some pictures as proof of what happened.Action taken in response to the event was unknown.The outcome of the event was not resolved.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.Evaluation of attached affiliate photo does not provide evidence to support a defective product.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Site sample status: photos received.Follow-up (22feb2021): follow-up attempts completed.No further information expected.Follow-up (16feb2021): new information received from product quality complaints (pqc) group included: updated suspect product and provided product quality 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: 11351056
• MDR Text Key: 241470681
• Report Number: 1066015-2021-00023
• 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
• Report Date: 02/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention