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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Tissue Damage (2104); Urticaria (2278); Discomfort (2330); Skin Inflammation (2443)

Event Type  Injury  

Event Description

Event verbatim [preferred term] blisters, have opened [blister] , hives had started to break open/skin is a mess [wound] , extremely uncomfortable [discomfort] , extremely uncomfortable and itchy [pruritus] , red blotche/still red [rash macular] , my skin felt irritated [skin irritation] , looked like hives/the hives had started to break open [urticaria] , painful [pain].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 at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.The patient previously used thermacare heatwraps for product used for unknown indication and experienced no adverse effect.The patient used the last menstrual wrap in a box of 3, and reported "after a few hours i noticed my skin felt irritated where the wrap was.Removed the wrap and noticed what looked like hives and red blotches.By the next day the hives had started to break open and become extremely uncomfortable and itchy.It's now been 3 days and all hives, or what i think might be blisters, have opened and my skin is a mess.Itchy, painful, and still red.Please advise on why this would happen - i've been using this product on/off for years and have never had this problem.I have a cabinet full of various wraps and now i'm hesitant to use them - or purchase more in the future.I cannot return them, they were purchased end of 2018 using an (organization name) balance.I'm very frustrated." the action taken in response to the events 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 blisters and open wound as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events discomfort, itching, red blotches, irritation skin, hives and pain are non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of blisters and open wound as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events discomfort, itching, red blotches, irritation skin, hives and pain are non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] blisters, have opened/hives had started to break open/skin is a mess/extremely uncomfortable and itchy/red blotches/skin felt irritated/looked like hives/the hives had started to break open/painful [blister rupture] ,.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 at an unknown frequency for an unspecified indication.Lot number not available.The patient medical history and concomitant medications were not reported.The patient previously used thermacare heatwraps for product used for unknown indication and experienced no adverse effect.The patient used the last menstrual wrap in a box of 3, and reported "after a few hours i noticed my skin felt irritated where the wrap was.Removed the wrap and noticed what looked like hives and red blotches.By the next day the hives had started to break open and become extremely uncomfortable and itchy.It's now been 3 days and all hives, or what i think might be blisters, have opened and my skin is a mess.Itchy, painful, and still red.Please advise on why this would happen - i've been using this product on/off for years and have never had this problem.I have a cabinet full of various wraps and now i'm hesitant to use them - or purchase more in the future.I cannot return them, they were purchased end of 2018 using an (organization name) balance.I'm very frustrated." the action taken in response to the events 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, #; batch t26693 and #-; 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 mar2016 - mar2019.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.Follow-up (24apr2019): new information received from a product quality complaint group included: investigation results, and the events "blisters, have opened/hives had started to break open/skin is a mess/extremely uncomfortable and itchy/red blotches/skin felt irritated/looked like hives/the hives had started to break open/painful" were combined and coded to "blister rupture".Company clinical evaluation comment: based on the information provided, the event "blister rupture" as described are 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 "blister rupture" as described are 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 pcom search returned a total of 84 complaints for menstrual products during this time period for the class/subclass.There were two complaints, #; batch t26693 and #-; 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 mar2016 - mar2019.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.

• 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: 8440961
• MDR Text Key: 139476890
• Report Number: 1066015-2019-00073
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• 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