MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE MENSTRUAL; DISPOSABLE PACK, HOT

Device Problem Material Integrity Problem (2978)

Patient Problems Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Event verbatim (preferred term) 3 burn blisters on my stomach (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 menstrual), from an unspecified date at an unknown frequency for pain management.The patient medical history and concomitant medications were not reported.The patient stated that she had been using these wraps recently and thought they were great.But now she had 3 burn blisters on her stomach on an unspecified date.The patient stated she didn't realize she could actually get burned by these.The patient asked, is it a product malfunction? or is this a common risk? the action taken in response to the event and 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 "3 burn blisters" 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 "3 burn blisters" 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.

Manufacturer Narrative

Initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01feb2016 through 28feb2019 manufacturing site: pfizer (name)/complaint class: external cause adverse event/ complaint sub class: adverse event safety request investigation.The pcom search returned a total of 78 complaints for menstrual products during this time period for the class/subclass.Of the 78 complaints; 19 complaints had the batch number recorded as "unknown".The 59 remaining complaints were evaluated.There were two complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation, refer to attachment a.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for menstrual products, refer to attachment menstrual ae feb2016 - feb2019.There is no further action required.Investigation summary: the root cause category is non-assignable.Our 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.There is not a trend identified for the subclass of adverse event for menstrual products.Complaint confirmed?: no.

Event Description

Event verbatim [preferred term] 3 burn blisters on her stomach [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 menstrual), from an unspecified date at an unknown frequency for pain management.The patient medical history and concomitant medications were not reported.The patient stated that she had been using these wraps recently and thought they were great.But now she had 3 burn blisters on her stomach on an unspecified date.The patient stated she didn't realize she could actually get burned by these.The patient asked, is it a product malfunction? or is this a common risk? the action taken in response to the event and event outcome was unknown.According to product quality complaint group on 14mar2019 and 14mar2019: initial complaint assessment: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: scope: date contacted: 01feb2016 through 28feb2019 manufacturing site: pfizer (name)/complaint class: external cause adverse event/ complaint sub class: adverse event safety request investigation.The pcom search returned a total of 78 complaints for menstrual products during this time period for the class/subclass.Of the 78 complaints; 19 complaints had the batch number recorded as "unknown".The 59 remaining complaints were evaluated.There were two complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation, refer to attachment a.Based on this pcom search, there is not a trend identified for the subclass of adverse event safety request for investigation for menstrual products, refer to attachment menstrual ae feb2016 - feb2019.There is no further action required.Investigation summary: the root cause category is non-assignable.Our 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.There is not a trend identified for the subclass of adverse event for menstrual products.Complaint confirmed?: no.Follow-up (14mar2019): new information received from product quality complaints included: investigation results.Follow-up (14mar2019): new information received from product quality complaints included: investigation results.Company clinical evaluation comment: based on the information provided, the event of "3 burn blisters" 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.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of "3 burn blisters" 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.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Event Description

3 burn blisters on my stomach [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 menstrual), from an unspecified date at an unknown frequency for pain management.The patient medical history and concomitant medications were not reported.The patient stated that she had been using these wraps recently and thought they were great.But now she had 3 burn blisters on her stomach on an unspecified date.The patient stated she didn't realize she could actually get burned by these.The patient asked, is it a product malfunction? or is this a common risk? the action taken in response to the event and event outcome was unknown.According to product quality complaint group: the root cause category is non-assignable.Our 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.There is not a trend identified for the subclass of adverse event for menstrual products.Follow-up (14mar2019): new information received from product quality complaints included: investigation results.Company clinical evaluation comment: based on the information provided, the event of "3 burn blisters" 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.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the event of "3 burn blisters" 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.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

The root cause category is non-assignable.Our 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.There is not a trend identified for the subclass of adverse event for menstrual products.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8325215
• MDR Text Key: 135701792
• Report Number: 1066015-2019-00030
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention