MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK AND HIP; DISPOSABLE PACK, HOT

Lot Number L35856 01/08

Device Problems Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Scar Tissue (2060); Caustic/Chemical Burns (2549)

Event Date 03/28/2015

Event Type  Other  

Manufacturer Narrative

Company clinical evaluation comment: based on the information provided, the events acute chemical burn, burn infection, purulent discharge as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event heat wrap getting too hot (product quality issue) is considered contributory to the other events and related to the device use.This case meets initial 10-day eu and 30-day fda reportability.

Event Description

Acute chemical burn/ chemical burn on lower back/ pain caused by the heatwrap [chemical burn of skin].There was drainage of pus from the burn [purulent discharge].Was getting too hot [product quality issue].Chemical burn got infected [burn infection].Four scars color is purple/ a scar, may be size of index finger [scar].Did not check the skin under the wrap during use [device misuse].Case description: this is a spontaneous report from a contactable other hcp (nurse).A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back and hip) (lot # l35856 01/08, expiration date: dec2017) from (b)(6) 2015 for chronic lower back pain.Medical history included menopause from an unknown date and unknown if ongoing, neck pain from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing taking albuterol, hypertension from an unknown date and unknown if ongoing taking amlodipine, depression from an unknown date and unknown if ongoing taking cymbalta, chronic lower back pain from which she is under the care of a physician from an unknown date and ongoing, myofascial pain syndrome from an unknown date and unknown if ongoing taking gabapentin, thyroid disorder from an unknown date and unknown if ongoing taking turns and vitamin d3 and arthralgia from an unknown date and unknown if ongoing taking lidocaine 5% ointment.Concomitant medication included salbutamol (albuterol) inhaler 90 mcg, 2 puffs every 6 hours for wheezing copd, amitriptyline (amitriptyline) 25 mg tablet by mouth at bed time for chronic lower back pain, amlodipine (amlodipine) 5 mg tablet once daily for hypertension, calcium carbonate (tums) 200 mg twice daily for thyroid, colecalciferol (vit d3) 2000 units once daily and an additional dose on wednesdays for thyroid, duloxetine hydrochloride (cymbalta) 1 tablet by mouth once daily for depression, gabapentin (gabapentin) 800 mg tablet 3 times daily for cervical pain and myofascial pain, lidocaine (lidocaine) 5% ointment 3 times daily for chronic right hip pain, nabumetone (nabumetone) 750 mg tablet twice daily for chronic lower back pain, omeprazole (prilosec) 20 mg capsules twice daily for an unspecified indication, and tiotropium bromide (spiriva) inhaler capsule for unspecified indication.Past product history included thermacare heatwraps (thermacare heatwraps) on an unspecified date for an unspecified indication with no adverse effects.On (b)(6) 2015, the patient reported at 10 am after taking her shower, she dried and dressed then applied the heatwrap over her t-shirt and proceeded with her day.The consumer mentioned that she was wearing the wrap for 2 and half hours on the day she got her burns and that the heatwrap was getting too hot and she took it off.She was still experiencing pain but it was pain caused by the heatwrap.The pain never stopped after starting on (b)(6) 2015.The patient was seen in urgent care and a physician informed her she had experienced an acute chemical burn, accident caused by caustic and corrosive substance and advised her to call pfizer.Urgent care informed her there was nothing they could do for the chemical burn on lower back and she should let it scab over.The patient reported "4 scars, color is purple." the patient did not check the skin under the heatwrap during product use.The patient mentioned that on (b)(6) 2015, the chemical burn got infected and on an unspecified date there was drainage of pus from the burn.The burn has healed now, it was just like a scar, may be size of index finger.The patient's skin tone was assessed as fair and skin colour as medium.She denied having sensitive skin or abnormal skin conditions.The patient mentioned that she put the wrap over her t-shirt so it was never on her bare skin, and she has been using heat wraps for over 2 years.The patient previously used electric heating pads as well as hot and cold patches with no adverse effects.She did not use any creams, rubs or gels under the wrap, did not engage in exercise while using the product, did not modify the wrap in any way, did not put the wrap in the microwave, did not use the wrap overnight or while sleeping, did not apply any kind of pressure over the wrap and did not use more than one wrap per day.The patient mentioned that there was no defect on the wrap like cuts, tears, leaks or holes and she read the usage instructions prior to product use.Action taken with the product was permanently withdrawn on (b)(6) 2015.Therapeutic measures received for burn included voltaren gel 1%, 100 g applying topically, 4 times a day above and below the burn area for the pain.The consumer mentioned that she did not undergo any blood work for her burns.Clinical outcome of the event of chemical burn of skin is recovered.The outcome of the scar and device misuse is not recovered.The outcome of burn infection, purulent discharge and product complaint was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (05/06/2015): new information from the same contactable other hcp (nurse) includes: reaction data (additional events: burn infection, purulent discharge, and product complaint), therapeutic measures and event outcome.

Manufacturer Narrative

The plant has reviewed this batch from a manufacturing a technical perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records do not provide evidence to support defective product.The product effect may vary with each individual.

Event Description

Additional information: follow-up (06/25/20105): new information received from the product complaint group included investigational results.Company clinical evaluation: comment: based on the information provided, the events acute chemical burn, burn infection, purulent discharge as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event heat wrap getting too hot (product quality issue) is considered contributory to the other events and related to the device use.This case meets follow up 10-day eu and 30-day fda reportability.

• Brand Name: THERMACARE LOWER BACK AND HIP
• 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 st. ; new york, NY 10017 ; 2127335544
• MDR Report Key: 4777187
• MDR Text Key: 24358814
• Report Number: 1066015-2015-00050
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2017
• Device Lot Number: L35856 01/08
• Date Manufacturer Received: 05/06/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 102