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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burning Sensation (2146); Skin Inflammation (2443); Burn, Thermal (2530)

Event Date 02/14/2018

Event Type  Injury  

Event Description

It burns!! i have used muscle rubs/pain relief creams in the past, and have never had a problem/my skin was never red so there was no reaction, just got very hot/tingly [thermal burn], case narrative:this is a spontaneous report from a non-contactable consumer.This (b)(6) year-old female consumer started to receive thermacare heatwrap (thermacare heatwrap) from unknown date to unknown date for unknown indication.Medical history and concomitant medications were not reported.On (b)(6) 2018, the consumer stated, "it burns!! i have used muscle rubs/pain relief creams in the past, and have never had a problem.I have never had any skin allergies or reactions to anything, but boy did this stuff burn after being on me for a few minutes.It subsided after about 10-15 minutes, and my skin was never red so there was no reaction, just got very hot/tingly." consumer stated the product burnt significantly more.The action taken in response to the events of the product was unknown.The outcome of event was resolving.No follow-up attempts are possible.No further information is expected.Follow-up (14feb2018): this case is being submitted to notify that the initial information for this case was first received by the company on 14feb2018 and not on 15feb2018 as previously reported.Initial supplier to safety was updated to measurable supplier other.Follow-up (14feb2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the event thermal burn as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Comment: based on the information provided, the event thermal burn as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.

• Brand Name: THERMACARE HEATWRAP
• 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: 9259950
• MDR Text Key: 184758778
• Report Number: 1066015-2019-00398
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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): Required Intervention
• Patient Age: 23 YR