MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMOCARE LOWER BACK AND HIP (THERMACARE HEATWRAP) WRAP; DISPOSABLE PACK, HOT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Other  

Event Description

Burn grade 2b [burns second degree].Case description: this is a spontaneous report from a contactable pharmacist.A (b)(6)-year-old male patient of an unspecified ethnicity started to receive thermacare heatwrap (thermacare lower back and hip) on an unspecified date for an unspecified indication.The patient's medical history included arrhythmia from an unknown date and unknown if ongoing.Concomitant medications included simvastatin (simvastatin), amiodarone (amiodaron), phenprocoumon (marcumar), tamsulosin (tamsulosin) and metoprolol tartrate (metohexal).The patient had previously used thermacare heatwraps without any reported problems.On an unspecified date, the patient experienced a burn with an approximate diameter of 2 cm on his lower back.It ws reported the treating physician had diagnosed the burn as grade 2b.Therapeutic measures taken included surgical removal of necrotic tissue on an unspecified date.It was reported treatment is ongoing and scar formation is expected.Action taken with the product was unknown.At the time of the report, clinical outcome of the event was not recovered.A causal relationship was confirmed.Follow-up attempts completed.No further information expected.Based on the available information, there was a reasonable possibility that the reported event of "burn with an approximate diameter of 2 cm on his lower back" diagnosed as burn second degree, was related to the use of thermacare lower back and hip.The case will be reevaluated should additional information become available.

• Brand Name: THERMOCARE LOWER BACK AND HIP (THERMACARE HEATWRAP) WRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; albany GA
• Manufacturer (Section G): PFIZER; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: 219 east 42nd street; new york, NY 10017 ; 2127335544
• MDR Report Key: 4188336
• MDR Text Key: 5094837
• Report Number: 1066015-2014-00006
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/09/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMIODARON (AMIODARONE),; SIMVASTATIN (SIMVASTATIN),; TAMSULOSIN (TAMSULOSIN),; MARCUMAR (PHENPROCOUMON),; METOHEXAL (METOPROLOL TARTRATE)
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 79