MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

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

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Event verbatim [preferred term]; burns on my neck [thermal burn], my neck is more painful than before [neck pain], my neck is more painful than before [condition aggravated].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age and ethnicity started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) via an unspecified route of administration from an unspecified date at an unspecified dose for neck pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient bought the neck wraps due to a sudden onset of neck pain, and after 8 hours removed it.The next day, she had burns on her neck and had to go back to the pharmacy for burn cream.She used the patch according to the instructions and now her neck was more painful than before.The outcome of the events 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 reported event thermal burn as described in this case is considered 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 other events neck pain and condition aggravated are assessed as associated with the device use.Comment: based on the information provided, the reported event thermal burn as described in this case is considered 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 other events pain and condition aggravated are assessed as associated with the device use.

Event Description

Event verbatim [preferred term] burns on my neck [thermal burn] , my neck is more painful than before [neck pain] , my neck is more painful than before [condition aggravated], case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) via an unspecified route of administration from an unspecified date at an unspecified dose for neck pain.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient bought the neck wraps due to a sudden onset of neck pain, and after 8 hours removed it.The next day she had burns on her neck and had to go back to the pharmacy for burn cream.She used the patch according to the instructions and now her neck was more painful than before.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Amendment: this follow-up report is being submitted to amend previously reported information: malfunction was left blank.Company clinical evaluation comment based on the information provided, the reported event thermal burn as described in this case is considered 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 other events neck pain and condition aggravated are assessed as associated with the device use., comment: based on the information provided, the reported event thermal burn as described in this case is considered 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 other events pain and condition aggravated are assessed as associated with the device use.

Event Description

Event verbatim [preferred term]; burns on my neck [thermal burn], my neck is more painful than before [neck pain], my neck is more painful than before [condition aggravated], narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date for neck pain.The patient's medical history and concomitant medications were not reported.The patient bought the neck wraps due to a sudden onset of neck pain, and after 8 hours removed it.The next day she had burns on her neck and had to go back to the pharmacy for burn cream.She used the patch according to the instructions and now her neck was more painful than before.The outcome of the events was unknown.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 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.Site sample status: not received amendment: this follow-up report is being submitted to amend previously reported information: malfunction was left blank.Follow-up (30apr2020): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the reported event thermal burn as described in this case is considered 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 other events pain and condition aggravated are assessed as associated with the device use.

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 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.Site sample status: not received.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 6169302
• MDR Text Key: 62221842
• Report Number: 1066015-2016-00164
• 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: 12/01/2016

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: Not provided
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/14/2019; 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention