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 Injury (2348); Burn, Thermal (2530)

Event Type  Injury  

Event Description

It burned my back [thermal burn].Case narrative: this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip l/xl) on an unknown date for unknown indication.Relevant medical history and concomitant medications were not reported.On an unknown date the patient experienced burn on back.The action taken with thermacare heatwrap and outcome of the event were unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event thermal burn as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Comment: based on the information provided, the event thermal burn as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] it burned my back [thermal burn].Case narrative:this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip) on an unknown date for unknown indication.Relevant medical history and concomitant medications were not reported.On an unknown date the patient experienced burn on back.The action taken with thermacare heatwrap and outcome of the event were unknown.Product quality complaints provided severity of harm rating of s3 and there was reasonable suggestion of device malfunction.The lot/batch number was not available.Additional information has been requested and will be provided as it becomes available.Follow-up (06feb2020): new information from product complaint group includes reasonably suggest device malfunction and severity of harm.Lot/batch number was still not available.Company clinical evaluation comment: based on the information provided, the event thermal burn as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event thermal burn as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

Manufacturer Narrative

Site sample status is not received.Pr state is closed.Summary of investigation is as follows: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion is as follows: 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 and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.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 product being packaged.Lot trend assmt.& rationale is a lot trend was not performed as the lot number is unknown.

Event Description

Event verbatim [preferred term] it burned my back [thermal burn].Case narrative:this is a spontaneous report from a contactable consumer.This consumer of unknown age and gender started to receive thermacare heatwrap (thermacare lower back & hip) on an unknown date for unknown indication.Relevant medical history and concomitant medications were not reported.On an unknown date the patient experienced burn on back.The action taken with thermacare heatwrap and outcome of the event were unknown.Product quality complaints provided severity of harm rating of s3 and there was reasonable suggestion of device malfunction.The lot/batch number was not available.According to product quality complaint group on 20mar2020: site sample status is not received.Pr state is closed.Summary of investigation is as follows: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion is as follows: 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 and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.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 product being packaged.Lot trend assmt.& rationale is a lot trend was not performed as the lot number is unknown.Follow-up (06feb2020): new information from product complaint group includes reasonably suggest device malfunction and severity of harm.Lot/batch number was still not available.Follow-up (19feb2020): this follow up report contains no new medically significant information.Follow-up (20mar2020): new information received from product quality complaint group includes investigation results., comment: based on the information provided, the event thermal burn as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.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: 9688484
• MDR Text Key: 189321732
• Report Number: 1066015-2020-00036
• 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: 02/02/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/20/2020; 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention