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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Tissue Damage (2104); Burning Sensation (2146); Burn, Thermal (2530); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Burn with redness and detaching skin [thermal burn], burn with redness and detaching skin [skin exfoliation].Case narrative: this is a spontaneous report from a contactable consumer or other non healthcare professional via medical information team.A female patient of an unspecified age started to use thermacare heatwrap (thermacare menstrual) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported during the last usage of the heatwrap she observed an issue.She felt a strong, selective burning sensation while using the heatwrap.When she checked it, she found she had an approximately 2 centimeter burn at this point.This burn was shown by reddening and a gradual detachment of skin.The patient ended the application immediately, of course.Action taken with the suspect product was permanently withdrawn on an unspecified date.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes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 thermal burn and skin exfoliation as described are considered serious bodily 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 thermal burn and skin exfoliation as described are considered serious bodily 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

Event verbatim [preferred term] burn with redness and detaching skin [thermal burn] , burn with redness and detaching skin [skin exfoliation].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare menstrual) from an unspecified date for an unspecified indication.The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient reported during the last usage of the heatwrap she observed an issue.She felt a strong, selective burning sensation while using the heatwrap.When she checked it, she found she had an approximately 2 centimeter burn at this point.This burn was shown by reddening and a gradual detachment of skin.The patient ended the application immediately, of course.Action taken with the suspect product was permanently withdrawn on an unspecified date.Clinical outcome of the events was unknown.The product quality complaint group provided the following investigation results.Reasonably suggest device malfunction was yes, severity of harm was s3 and site sample status was not received.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/serious/unknown.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 (30mar2020): new information from the product quality complaint group included: investigation results.Additional information has been requested and will be provided as it becomes available., comment: based on the information provided, the events thermal burn and skin exfoliation as described are considered serious bodily 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.

Manufacturer Narrative

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/serious/unknown.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: 9884615
• MDR Text Key: 185601515
• Report Number: 1066015-2020-00087
• 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
• Report Date: 03/16/2020

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention