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

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Event Description

Event verbatim [preferred term] burn blister (burns second degree).Case narrative: this is a spontaneous report from a pfizer-sponsored program brand websites for devision consumer healthcare (b)(6) from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported that she had been using heat wraps for many years.This time she experienced burn blister caused by thermacare shoulder patch on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome 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 of burns second degree 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 of burns second degree 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] burn blister [burns second degree].Case narrative:this is a spontaneous report from a pfizer-sponsored program brand websites for devision consumer healthcare germany from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist, no lot number) from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported that she had been using heat wraps for many years.This time she experienced burn blister caused by thermacare shoulder patch on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (18jul2018): this follow-up is being submitted to notify that an investigation of the device cannot be conducted.Follow-up attempts have been completed and no further information is expected.Company clinical evaluation comment: based on the information provided, the event of burns second degree 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 of burns second degree 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], burn blister [burns second degree], narrative: this is a spontaneous report from a pfizer-sponsored program brand websites for division consumer healthcare germany from a contactable consumer (patient).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist, no lot number) from an unspecified date at an unspecified frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient reported that she had been using heat wraps for many years.This time she experienced burn blister caused by thermacare shoulder patch on an unspecified date.The action taken in response to the event for thermacare heatwrap was unknown.The event outcome was unknown.According to product quality group: site sample status: not received.Conclusion of investigational report: 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 (18jul2018): follow-up attempts have been completed and no further information is expected.Follow-up (29may2020): new information received from product quality complaint group includes investigation results.Follow-up attempts are completed.No further information is expected.

Manufacturer Narrative

Site sample status: not received.Conclusion of investigational report: 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 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: 7549471
• MDR Text Key: 109515068
• Report Number: 1066015-2018-00071
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2018

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: 05/29/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/20/2018; 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention