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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); Burn, Thermal (2530)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] had a nasty sore created from a burn on my skin from this product/hurting [thermal burn], ended up being infected due to the location of it [localised infection], not being able to let it heal properly [impaired healing].Case narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), from an unspecified date in (b)(6) 2019 at an unknown frequency for pain management.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient previously took thermacare menstrual every month and had for years without any issues.The patient stated, "i have had a nasty sore created from a burn on my skin from this product.I use these every month and have for years without any issues.Well last week (in (b)(6) 2019) i had one on for 1-2 hours and it really started hurting.So i went to the bathroom and found that i had been burned by it.The burn turned into a sore that ended up being infected (on an unspecified date in 2019) due to the location of it and not being able to let it heal properly".The action taken in response to the event for thermacare heatwrap 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 events of "burn turned into a sore that ended up being infected to the location of it and not being able to let it heal properly" as described are considered serious injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "burn turned into a sore that ended up being infected to the location of it and not being able to let it heal properly" as described are considered serious injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Event Description

Had a nasty sore created from a burn on my skin from this product/hurting [thermal burn], ended up being infected due to the location of it [localised infection], not being able to let it heal properly [impaired healing].Case narrative: this is a spontaneous report from a contactable consumer (patient).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), from an unspecified date on (b)(6) 2019 at an unknown frequency for pain management.The patient medical history was not reported.The patient's concomitant medications were not reported.The patient previously took thermacare menstrual every month and had for years without any issues.The patient stated, "i have had a nasty sore created from a burn on my skin from this product.I use these every month and have for years without any issues.Well last week (on (b)(6) 2019) i had one on for 1-2 hours and it really started hurting.So i went to the bathroom and found that i had been burned by it.The burn turned into a sore that ended up being infected (on an unspecified date in 2019) due to the location of it and not being able to let it heal properly".The action taken in response to the event for thermacare heatwrap and event outcome was unknown.According to product quality complaint group: the pcom search returned a total of 84 complaints for menstrual products during this time period for the class/subclass.There were two complaints, #/pr-#; batch: t26693 and #/pr-#; batch: t26691 confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The root cause was identified as equipment - other.Known capa's for the confirmed complaints are listed below.The preliminary assessment did not identify a cause related to the investigations mentioned above.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 the attached trend chart for march 2016 - march 2019.There is no further action required.Investigation summary: 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.There is no further investigation or actions required.Follow-up (24apr2019): new information received from product quality complaints group included: investigation results.Company clinical evaluation comment: based on the information provided, the events of "burn turned into a sore that ended up being infected to the location of it and not being able to let it heal properly" as described are considered serious injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are 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 events of "burn turned into a sore that ended up being infected to the location of it and not being able to let it heal properly" as described are considered serious injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are 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 pcom search returned a total of 84 complaints for menstrual products during this time period for the class/subclass.There were two complaints, #/pr-#; batch: t26693 and #/pr-#; batch t26691 confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The root cause was identified as equipment - other.Known capa's for the confirmed complaints are listed below.The preliminary assessment did not identify a cause related to the investigations mentioned above.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 the attached trend chart for march 2016 - march 2019.There is no further action required.Investigation summary: 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.There is no further investigation or actions required.

• 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: 8413137
• MDR Text Key: 138767831
• Report Number: 1066015-2019-00064
• 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
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention