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 Problems Fluid Discharge (2686); Full thickness (Third Degree) Burn (2696)

Event Date 02/27/2016

Event Type  Injury  

Event Description

Third degree burn on lower back about the size of a half dollar.It is still seeping fluid.Case description: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare lower back and hip) , from an unspecified date since they came out for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.Past product included thermacare neck wraps since they came out and never had any problems.The patient reported "i have used the lower back and neck wraps since they came out and never had any problems with them until (b)(6) 2016.I put on lower back just like i always have and got a third degree burn on my lower back about the size of a half dollar.It has been three weeks and it is still seeping fluid".Events were occurred on (b)(6) 2016 with outcome not resolved.The action taken in response to the events were permanently discontinued on (b)(6) 2016.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment / case comment: based on the information provided, the event "third degree burn on my lower back about and it is still seeping fluid" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Third degree burn on lower back about the size of a half dollar [burns third degree], it is still seeping fluid [wound secretion].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), from an unspecified date since they came out for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.Past product included thermacare neck wraps since they came out and never had any problems.The patient reported "i have used the lower back and neck wraps since they came out and never had any problems with them until (b)(6) 2016.I put on lower back just like i always have and got a third degree burn on my lower back about the size of a half dollar.It has been three weeks and it is still seeping fluid".Events were occurred on (b)(6) 2016 with outcome not resolved.The action taken in response to the events were permanently discontinued on (b)(6) 2016.The product quality complaint group provided the following investigation results.Reasonably suggest device malfunction was no, severity of harm was not applicable and site sample status was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: 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 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 (13may2016): follow-up attempts completed.No further information expected.Follow-up (18jul2020): new information received from the product quality complaint group included: investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (29apr2020): this case is being submitted to notify that the follow-up information previously considered to have been initially received by the company on 18jul2020 was instead received on 29apr2020.Comment: based on the information provided, the event "third degree burn on my lower back about and it is still seeping fluid" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the events are assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

Reasonably suggest device malfunction was no, severity of harm was not applicable and site sample status was not received.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Conclusion: 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 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.

• 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: 5531635
• MDR Text Key: 41347422
• Report Number: 1066015-2016-00054
• 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: 03/20/2016

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: 03/20/2016
• Initial Date FDA Received: 03/29/2016
• Supplement Dates Manufacturer Received: 03/20/2016
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention