MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Lot Number E88980 S

Device Problems Device Expiration Issue (1216); Device Operates Differently Than Expected (2913)

Patient Problems Fever (1858); Itching Sensation (1943); Nausea (1970); Pain (1994); Scar Tissue (2060); Full thickness (Third Degree) Burn (2696)

Event Date 01/04/2015

Event Type  Injury  

Event Description

Three degree burn in the back on the left neck [burns third degree], drainage of pus from the burns/ burn + green pus [purulent discharge] felt the heatwrap was getting too hot [product quality issue], nauseating [nausea], used an expired product! product was expired [device misuse], fever [pyrexia], bumps and itchy neck/ itchy + bumpy scar [pruritus], bumpy scar [scar], skin came out [skin exfoliation].Case description: this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare neck, shoulder and wrist) (lot#: e88980, expiration date: nov 2013) from an unspecified date in 2014 (reported as 6 to 7 months ago) for neck pain and stiff neck.The patient's medical history was not reported.Concomitant medication included ibuprofen (advil) 2 dose forms at unspecified frequency for neck pain.Past product history included thermacare heatwraps (thermacare heatwraps) on an unspecified date for an unspecified indication.On (b)(6) 2015, the patient reported using the heatwrap in the morning for approximately 3 hours and experienced a third degree burn on the back of her neck on the left side with swelling, redness all over her neck, skin came out and drainage of green pus.She stated she felt the heatwrap was getting too hot.The patient mentioned she was nauseated and had pain and fever.The patient reported the product had expired in nov 2013.She called her physician who instructed her to visit an urgent care facility where she was provided with unspecified medications for treatment.The patient stated she was hospitalized "for a week or so" on an unspecified date for an unspecified indication and was prescribed unspecified medications.She mentioned she is still experiencing "itchy and bumpy scar on neck".The patient stated the symptoms lasted approximately 7-10 days.Action taken with the suspect product was permanently withdrawn on an unspecified date.At the time of the report, clinical outcome of the events was not resolved.The patient assessed her skin tone as dark or olive.She denied having sensitive skin or having any abnormal skin conditions.The patient reported she did not use any creams, rubs or gels under the wrap and did not find any defects on the wrap like cuts, tears, leaks or holes.She reported she did not change or modify the wrap in anyway.The patient stated she did not put the wrap in the microwave and did not exercise while using the product.She mentioned she did use the wrap over healthy skin and over the correct part of the body.The patient reported she did not apply any pressure over the wrap and did not wear more than two layers of clothing over the wrap.She mentioned she did not sit or recline for a prolonged period of time and did not use more than one wrap per day.The patient stated she previously used other heat products for pain relief such as an electric heating pad, hot water bottle or microwave gel pack and never experienced an adverse event.She reported she did check the skin under the product while wearing the heatwrap.The patient mentioned reading the usage instructions prior to using the product.

Manufacturer Narrative

Additional information received from product quality complaint (pqc) group provided quality assurance (qa) investigation results.The plant has reviewed this batch from a manufacturing and 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 the wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective products.The product effect may vary with each individual.Additional information has been requested and will be provided as it becomes available.Follow-up (07jan2015): new information received from product quality department includes: the lot number provided is not valid.Follow up (14jan2015): new information received from product quality department includes: valid lot number and expiration date.Follow-up (08mar2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.Follow-up (11mar2015): new information received from a contactable consumer includes: suspect product indication, therapeutic measures received, additional events of scar, skin exfoliation and itching, event outcome, patient hospitalization and upgrading this case to serious reportable medical device report.Company case comment: based on the information provided, a possible contributory role of the suspect device product to the reported events cannot be excluded.This case meets initial 30 day reportability.Evaluation summary the plant has reviewed this batch from a manufacturing and 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 the wrap.The cause of the alleged burn is inconclusive since review of records does not provide evidence to support defective products.The product effect may vary with each individual.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH 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: 4638523
• MDR Text Key: 5614869
• Report Number: 1066015-2015-00013
• 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: Consumer
• Type of Report: Initial
• Report Date: 01/05/2015

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: 11/01/2013
• Device Lot Number: E88980 S
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 03/26/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 52