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 Irritation (1941); Rash (2033); Disability (2371); Burn, Thermal (2530)

Event Date 11/01/2018

Event Type  Injury  

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.There is not a trend identified for the subclass of adverse event for menstrual products, refer to attachment adverse event menstrual (b)(6) 2015 - (b)(6) 2018 trending graph.Adverse events for burns show peaks in (b)(6) 2018.Thermacare burn rate surveillance was included in management review on (b)(4) 2019.In the most recent 6 month period ((b)(4) 2018), an increase in % burn reports follows upward trend of total sales.However, cases/million wraps continues to be very stable at (b)(4).No trend; the burn rate is within ppm.

Event Description

Event verbatim [preferred term] sustained burns and irritating rash like symptoms as a result [thermal burn], sustained burns and irritating rash like symptoms as a result [rash].Case narrative: this is a spontaneous report from a contactable consumer based on the information received by pfizer via us fda (report number: mw5081710).A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare menstrual), topically in 2018 as needed for pelvic pain.Relevant medical history and concomitant medications were not reported.The patient experienced sustained burns and irritating rash like symptoms as a result of using the product on (b)(6) 2018.Event report type was reported as serious injury.Event outcome was reported as disability/ permanent damage.The action taken in response to the events for thermacare heatwrap was permanently withdrawn in 2018.The outcome of the events was unknown.According to the product quality complaint group: device lot number was reported as b010b4d20, but number provided determined to be invalid as per sap/site per.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.There is not a trend identified for the subclass of adverse event for menstrual products, refer to attachment adverse event menstrual (b)(6) 2015 - (b)(6) 2018 trending graph.Adverse events for burns show peaks in (b)(6) 2018.Thermacare burn rate surveillance was included in management review on (b)(6) 2019.In the most recent 6 month period ((b)(6) 2018), an increase in % burn reports follows upward trend of total sales.However, cases/million wraps continues to be very stable at (b)(4).No trend; the burn rate is within ppm.No follow-up attempts are possible.No further information is expected.Follow-up (22feb2019): new information received from product quality complaint group includes investigation results.The case upgraded to serious (medically significant and interventional required).No follow-up attempts are possible.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of thermal burn and rash 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 of thermal burn and rash 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.

• Brand Name: THERMACARE MENSTRUAL
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 8386310
• MDR Text Key: 137800666
• Report Number: 1066015-2019-00052
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2018

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: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention