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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 12/01/2015

Event Type  Injury  

Event Description

Quite a large burn on my back [thermal burn].Case description: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare lower back & hip), in (b)(6) 2015, to an unspecified date at an unknown frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient reported "i used one of these wraps for the first time yesterday and have quite a large burn on my back.It is only one spot and off to the side so it was not a pressure point.I sit on a ball chair without a back at my desk so i wasn't leaning on.In fact, there was no pressure on it at all" in (b)(6) 2015 with the outcome of unknown.The action taken with thermacare heatwrap was 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 in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event thermal burn as described in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Quite a large burn on my back [thermal burn]; scabbed over for the third time [scab].Case description: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to use thermacare heatwrap (thermacare lower back & hip), in (b)(6) 2015, to an unspecified date at an unknown frequency for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient reported "i used one of these wraps for the first time yesterday and have quite a large burn on my back.It is only one spot and off to the side so it was not a pressure point.I sit on a ball chair without a back at my desk so i wasn't leaning on.In fact, there was no pressure on it at all" in (b)(6) 2015.The patient confirmed the heatwrap was not prescribed.She treated the burn with neosporin and it has scabbed over for the third time.The action taken with thermacare heatwrap and the outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Follow up (18dec2015): new information from a contactable consumer includes: reaction data (additional event: scab) and therapeutic measures.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the event thermal burn as described in this case is considered a serious bodily injury.Potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event scab is assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the event thermal burn as described in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event scab is assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.

Manufacturer Narrative

There was no reasonable suggestion of device malfunction.Sample status at the side was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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, 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 safety request for investigation.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.

Event Description

Event verbatim [preferred term] quite a large burn on my back [thermal burn], scabbed over for the third time [scab], narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip), in (b)(6) 2015, to an unspecified date at an unknown frequency for an unspecified indication.The patient's medical history and concomitant medications were not reported.The patient reported "i used one of these wraps for the first time yesterday and have quite a large burn on my back.It is only one spot and off to the side so it was not a pressure point.I sit on a ball chair without a back at my desk so i wasn't leaning on.In fact, there was no pressure on it at all" in (b)(6) 2015.The patient confirmed the heatwrap was not prescribed.She treated the burn with neosporin and it has scabbed over for the third time.The action taken with thermacare heatwrap and the outcome of the events was unknown.According to product quality complaints: there was no reasonable suggestion of device malfunction.Sample status at the side was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.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, 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 safety request for investigation.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.Follow up (18dec2015): new information from a contactable consumer includes: reaction data (additional event: scab) and therapeutic measures.Follow-up attempts completed.No further information expected.Follow-up (09jun2020): new information received from a product quality complaints includes investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the event thermal burn as described in this case is considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event scab is assessed as associated with the device use.This case meets final 10-day eu and 30-day fda reportability.

• 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: 5323946
• MDR Text Key: 34271426
• Report Number: 1066015-2015-00160
• 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: 12/10/2015

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided; 12/18/2015
• Supplement Dates FDA Received: 01/13/2016; 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention