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 consumer report with the FDA on 2020-03-26 for THERMACARE LOWER BACK & HIP manufactured by Pfizer Consumer Health Care.

Event Text Entries

[185085047] 3rd degrees burned [burns third degree]. Case narrative: this is a spontaneous report from a contactable consumer. A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), unknown device lot number and expiry date, from an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient stated she put in a complaint last year in 2019 and she threw the stuff away. She stated she had 3rd degrees burned by the thermacare back pain therapy heatwraps, clarifying that this initially happened in (b)(6) 2019. She stated that she always used the product but now she did not because she was scared. The patient stated that she no longer had the product. She threw it away so she cannot send it back. The action taken in response to the event for the product was unknown. The event outcome was unknown. Additional information has been requested and will be provided as it becomes available. Comment: based on the information provided, the event burns third degree 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: 1066015-2020-00085
• MDR Report Key: 9884612
• Report Source: CONSUMER
• Date Received: 2020-03-26
• Date of Report: 2020-03-17
• Date of Event: 2019-07-01
• 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 LOWER BACK & HIP
• Generic Name: DISPOSABLE PACK, HOT
• Product Code: IMD
• Date Received: 2020-03-26
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• 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