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); Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Received a 1 inch burn blister on her shoulder after wearing the patch [burns second degree].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 neck, shoulder & wrist), from an unspecified date for an unspecified indication.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient received a 1 inch burn blister on her shoulder after wearing the patch on an unspecified date, this was the first time using.The outcome of the event 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 "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is 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 "burn blister" as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Event verbatim [preferred term] received a 1 inch burn blister on her shoulder after wearing the patch [burns second degree].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), from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient received a 1 inch burn blister on her shoulder after wearing the patch on an unspecified date, this was the first time using.The action taken for the product and the outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (01jun2016): follow-up attempts are completed.No further information is expected.Follow-up (07feb2020): new information received from product quality complaint group included: investigation was ongoing, and malfunction was left blank.Company clinical evaluation comment.Based on the information provided, the event "burn blister " as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability., comment: based on the information provided, the event "burn blister " as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is 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 neck/shoulder/wrist (nsw) 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.

Event Description

Event verbatim [preferred term].Received a 1 inch burn blister on her shoulder after wearing the patch [burns second degree].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), from an unspecified date for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient received a 1 inch burn blister on her shoulder after wearing the patch on an unspecified date, this was the first time using.The action taken for the product and the outcome of the event was unknown.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 neck/shoulder/wrist (nsw) 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 (01jun2016): follow-up attempts are completed.No further information is expected.Follow-up (07feb2020): new information received from product quality complaint group included: investigation was ongoing, and malfunction was left blank.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 (06may2020): 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 06may2020.Comment: based on the information provided, the event "burn blister " as described in this case is considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event is assessed as associated with the use of the device.This case meets initial 10-day eu and 30-day fda reportability.

• 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: 5607989
• MDR Text Key: 43641894
• Report Number: 1066015-2016-00064
• 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: 04/06/2016

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: 04/06/2016
• Initial Date FDA Received: 04/26/2016
• Supplement Dates Manufacturer Received: 04/06/2016; 04/06/2016
• Supplement Dates FDA Received: 02/14/2020; 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention