THERMACARE MENSTRUAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-26 for THERMACARE MENSTRUAL manufactured by Pfizer Consumer Health Care.

Event Text Entries

[185601515] 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 Action taken with the suspect product was permanently withdrawn on an unspecified date.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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1066015-2020-00087
• MDR Report Key: 9884615
• Report Source: CONSUMER,FOREIGN
• Date Received: 2020-03-26
• Date of Report: 2020-03-16
• Date Added to Maude: 2020-03-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS STELLA PIETRAFESA
• Manufacturer Street: 235 E42ND STREET
• Manufacturer City: NEW YORK NY 10017
• Manufacturer Country: US
• Manufacturer Postal: 10017
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THERMACARE MENSTRUAL
• Generic Name: DISPOSABLE PACK, HOT
• Product Code: IMD
• Date Received: 2020-03-26
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PFIZER CONSUMER HEALTH CARE
• Manufacturer Address: 1231 WYANDOTTE DRIVE ALBANY GA 31705 US 31705

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-26