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

Lot Number H88688

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Purulent Discharge (1812); Inflammation (1932); Pain (1994); Skin Discoloration (2074); Swelling (2091); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 08/07/2014

Event Type  Other  

Event Description

Severe burns on the right side of lower back, mentioned as 2nd and 3rd degree burns [burns third degree].Severe burns on the right side of lower back, mentioned as 2nd and 3rd degree burns/burn lower back [burns second degree].Drainage of pus from the burns [purulent discharge].Case description: this is a spontaneous report from a contactable physician and a contactable consumer.This (b)(6) female consumer of mixed ethnicity started to use thermacare heatwrap (thermacare lower back & hip) (lot# h88688, exp date: oct2016) on (b)(6) 2014 once topically for minor back pain.Relevant medical history and relevant concomitant medications were not reported.There were no reported drug allergies and no family history.The consumer reported that since (b)(6) 2014 (physician reported as (b)(6) 2014), she had severe burns on right side of lower back, pain and swelling while using heatwrap described as 2nd and 3rd degree burns.The size of one burn was of a nipple and two were sizes of a dime, there was drainage of pus from the burns and she had pain and swelling.The patient saw a physician subsequent to the burns due to the heatwrap.The physician stated they did not prescribe this product, the patient used the product on their own.The physician reported a burn on the patient's lower back; superficial partial thickness burn 1cm and two 2 cm burns with pain.Relevant laboratory data was none.The consumer used heatwrap only once and stopped it on (b)(6) 2014.Therapeutic measures taken in response to the events included bactroban and non stick dressing by a physician.No surgical intervention such as debridement was required.The patient was not deceased.Clinical outcome of the event was reported as still healing at the time of report.The physician considered the events were likely due to thermal burn 212 wrap, and related to thermacare heatwrap.The physician did not know if the patient would experience longterm sequelae such as scarring, but reported possible scarring or post inflammation hyperpigmentation.The consumer's skin tone was medium, she didn't use any creams, rubs or gels under the wrap, she used the thermacare for first time, there was no defect on the wrap like cuts, tears, leaks or holes, she did not change or modify the wrap in anyway, she did not use the wrap overnight or while sleeping, she did not microwave the wrap, she used the wrap over healthy skin and she used the wrap over the correct part of the body.She did not exercise while using the wrap, she did not apply any pressure over the wrap, she did not wear more than two layers of clothing over the wrap, she used only 1 wrap and for 7 hours only.She mentioned that the heatwrap was warm and not too hot.Additional information received from product quality complaint (pqc) group provided quality assurance (qa) investigation results.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 in date.All of our operations employ strict quality control procedures which include statistical sampling and visual inspection to ensure the quality of the product being packaged.A corrective action procedure for an individual cell temperature less than the individual cell temperature lower specification limit was completed for run day one.The wrap was checked for analytical or material failures that could have caused a cold cell, none were identified.Consumer alleges burn from wrap.The cause of the alleged bum is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.If additional information regarding this complaint is provided and the circumstances relating to the consumer's use of the product changes the conclusion and the origin of the complaint, this complaint evaluation report will be revised to reflect the changes.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Follow-up (25aug2014): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.Follow-up (15sep2014): new information received from a contactable physician includes: updated patient age, physician confirmed the occurrence of the events reported by the patient, medically confirming the case, action taken with suspect product, route of administration, product stop date, therapeutic measures received, event outcome and causality assessment.Follow-up attempts completed.No further information expected.Company comment: based on the available information, the company cannot exclude a possible contribution of the suspect device product to the events of 2nd and 3rd degree burns with drainage of pus from the burns.This case is assessed as initial reportable case based on the follow up information.Evaluation summary: 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 in date.All of our operations employ strict quality control procedures, which include statistical sampling and visual inspection to ensure the quality of the product being packaged.A corrective action procedure for an individual cell temperature less than the individual cell temperature lower specification limit was completed for run day one.The wrap was checked for analytical or material failures that could have caused a cold cell, none were identified.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.If additional information regarding this complaint is provided and the circumstances relating to the consumer's use of the product changes the conclusion and the origin of the complaint, this complaint evaluation report will be revised to reflect the changes.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 in date.All of our operations employ strict quality control procedures which include statistical sampling and visual inspection to ensure the quality of the product being packaged.A corrective action procedure for an individual cell temperature less than the individual cell temperature lower spec limit was completed for run day one.The wrap was checked for analytical or material failures that could have caused a cold cell, none were identified.Consumer alleges burn from wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective product the product effect may vary with each individual.If additional information regarding this complaint is provided and the circumstances relating to the consumer's use of the product changes the conclusion and the origin of the complaint, this complaint evaluation report will be revised to reflect the changes.

• Brand Name: THERMACARE LOWER BACK AND HIP (THERMACARE HEATWRAP) WRAP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HLTH CARE; albany GA
• Manufacturer (Section G): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: 219 east 42nd st; new york, NY 10017 ; 2127335544
• MDR Report Key: 4136416
• MDR Text Key: 16082411
• Report Number: 1066015-2014-00005
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2014

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: 10/01/2016
• Device Lot Number: H88688
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 73