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

Lot Number F80438G

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Full thickness (Third Degree) Burn (2696)

Event Date 02/01/2014

Event Type  Injury  

Event Description

Diagnosed with "third degree" on/under her left breast [burns third degree].Woke up in pain after going to sleep [device misuse].Worsened breast pain [pain].Redness [erythema].Case description: this is a spontaneous report from a contactable attorney by way of claim letter.A female pt of an unspecified age and ethnicity used thermacare heatwrap (thermacare heatwrap) as directed on an unspecified date for unk indication.The lot number was f80438g and expiration date was 01/2015.The pt's medical history and concomitant medications were not reported.On an unk date, she experienced a bad burn on/under her left breast.At the time of the report, the clinical outcome of the event was unk.Additional info has been requested and will be provided as it becomes available.Follow-up ((b)(4) 2014): this contactable attorney reported by way of consumer questionnaire and medical records.(b)(6) year old female patient applied thermacare heatwrap (thermacare heatwrap) two hours only one time for sore on lower left shoulder (blade) on (b)(6) 2014.The relevant medical history included hypertension since an unk date and breast cancer on an unk date.The family history included coronary artery disease.The concomitant medication refilled with losartan (cozaar) 10 mg daily orally for hypertension since (b)(6) 2013.In (b)(6) 2014 after using thermacare heatwrap, the pt woke up in pain after going to sleep and diagnosed with "third degree".On (b)(6) 2014, the pt was hospitalized for the burns and discharged on the same date.The pt treated with sulfadiazine silver (silvadene) 25 gram once daily topically and hydrocodone/ paracetamol (norco) one tablet orally from (b)(6) 2014.On (b)(6) 2014, the pt had worsened breast pain, swelling and redness.The patient also treated with oxycodone/paracetamol (percocet) 5/325 mg tablet daily orally from (b)(6) 2014.Additional info has been requested and will be provided as it becomes available.

• Brand Name: THERMACARE HEATWRAP (THERMACARE HEATWRAP) WRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: 219 east 42nd street; new york, NY 10017-4147 ; 2127335544
• MDR Report Key: 4129150
• MDR Text Key: 15120340
• Report Number: 1066015-2014-00004
• 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: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/06/2014

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
• Device Expiration Date: 01/01/2015
• Device Lot Number: F80438G
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/18/2014
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR