THERMACARE LOWER BACK & HIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-27 for THERMACARE LOWER BACK & HIP manufactured by Pfizer Consumer Health Care.

Event Text Entries

[185602305] Skin burns [thermal burn]. Case narrative:this is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), lot number ap4309, expiration date feb-2022, pack of 4 for an unspecified indication. Relevant medical history and concomitant medications were not reported. The patient experienced skin burns not long ago on an unknown date. The pharmacist reported "3 fields have flowed together". The action taken in response to the event for thermacare heatwrap was not applicable. The outcome of the event was unknown. The severity of harm assessment received from (b)(6) is s3. Additional information has been requested and will be provided as it becomes available. Company clinical evaluation comment: based on the information provided, the event of "burn" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure. A causal relationship between the device and event cannot be ruled out. Comment: based on the information provided, the event of "burn" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure. A causal relationship between the device and event cannot be ruled out.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1066015-2020-00046
• MDR Report Key: 9766227
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-02-27
• Date of Report: 2020-02-11
• Date Added to Maude: 2020-02-27
• 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 LOWER BACK & HIP
• Generic Name: DISPOSABLE PACK, HOT
• Product Code: IMD
• Date Received: 2020-02-27
• Lot Number: AP4309
• 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	2020-02-27