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

Lot Number J20588

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Scarring (2061); Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2015

Event Type  Other  

Event Description

Second degree burns.Secondary bacterial infection (redness, moist, pus) [wound infection bacterial].Patch was used directly on the skin [device misuse].Pt had long-term sequelae: scarring.Case description: this is a spontaneous report from a contactable pharmacist.This report ws received via a sales representative.A (b)(6) female pt started to receive thermacare heatwrap (thermacare lower back and hip) (lot #: j20588, expiration date: 04/2017) topically from an unspecified date in (b)(6) 2014 at 1 patch daily for back pain.The patient's med history included ongoing neuropathy, ongoing epilepsy.Concomitant medications included tramadol hydrochloride (contramal retard) 150mg unk frequency, valproate sodium (depakine enteric) 500mg unk frequency, lorazepam (lorazepam) 2.5mg unk frequency, carbamazepine (tegretol cr) 400mg unk frequency and trazodone hydrochloride (trazolan) 100mg unk frequency.On an unspecified date in (b)(6) 2015, the pt applied the heatwrap directly to her skin and experienced second degree burns on her lower back.The pt was a frequent user of thermacare, but this was the first time she developed a burn.Therapeutic measures received included sulfadiazine (flammazine).The pt experienced a secondary bacterial infection (redness, moist, pus), on an unspecified dat, which was treated with hexamidine (hexomedine) transdermal and fusidinic acid (fucidine) cream.No surgical intervention was required.The pt had long term sequelae: scarring.Thermacare heatwrap was temporarily withdrawn in (b)(6) 2015.The heatwrap was reintroduced on an unspecified date in 2015 and it was unk if the event recurred.The pt was not taking any relevant medications, including topical, at the time of the event.The pharmacist considered thin skin as possible etiological factor.The customer would like to receive compensation for the cost of the treatment of the burns.Clinical outcome of the events was reported as recovering.Additional info has been requested and will be provided as it becomes available.

Manufacturer Narrative

Follow up (02/04/2015): new info received from a contactable pharmacist includes: pt details, suspect product details, med history, concomitant medications, event onset date, additional events of device misuse, wound infection bacterial and scarring, therapeutic measures and event outcome.Follow up attempts completed.No further info expected.Case comment: based on the available info, there was a reasonable possibility that the reported events of second degree burns resulting in long-term sequelae (scarring) and secondary bacterial infection were related to suspected product thermacare lower back and hip.

Manufacturer Narrative

Batch j20588 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for batch j20588.On the basis of this evaluation, a trend does not exist for this batch; therefore there is no further action required at this time.The evaluation of one retain sample shows no obvious defects.Review of the batch device history record for lot j20588 concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the three day run report a total of 46 wraps tested for individual cell temperature, wrap average temperature, and individual wrap temperature.All wraps met the required temperature specifications.There were no wrap attribute or variable defects recorded for the batch.The thermal and pti data were reviewed and there were no thermal or leak results outside the required specifications.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 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.Additional information has been requested and will be provided as it becomes available.Follow up (february 4, 2015): new information received from a contactable pharmacist includes: patient details, suspect product details, medical history, concomitant medications, event onset date, additional events of device misuse, wound infection bacterial and scarring, therapeutic measures received and event outcome.Follow-up attempts completed.No further information expected.Company comment: based on the available information, there was a reasonable possibility that the reported events of second degree burns resulting in long-term sequelae (scarring) and secondary bacterial infection were related to suspected product thermacare lower back and hip.Follow-up (june 29, 2015): new information received from product complaint group includes: product investigation result.Company clinical evaluation comment: based on the available information, there was a reasonable possibility that the reported events of second degree burns resulting in long-term sequelae (scarring) and secondary bacterial infection were related to suspected product thermacare lower back and hip.This case meets follow up 10-day eu and 30-day fda reportability.Case comment: based on the available information, there was a reasonable possibility that the reported events of second degree burns resulting in long-term sequelae (scarring) and secondary bacterial infection were related to suspected product thermacare lower back and hip.This case meets follow up 10-day eu and 30-day fda reportability.

Manufacturer Narrative

F/u (june 29, 2015): this f/u report is being submitted to amend previously reported info; this case is reportable as a final 10-day eu and 30-day fda medical device report.

• Brand Name: THERMACARE LOWER BACK & 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 dr; albany GA 31705
• Manufacturer Contact: 219 e 42nd st; new york, NY 10017 ; 2127335544
• MDR Report Key: 4534204
• MDR Text Key: 5515719
• Report Number: 1066015-2015-00004
• 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: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 01/15/2015

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: 04/01/2017
• Device Lot Number: J20588
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TRAZOLAN (TRAZODONE HYDROCHLORIDE); CONTRAMAL RETARD (TRAMADOL HYDROCHLORIDE); LORAZEPAM (LORAZEPAM); NEXIAM (ESOMEPRAZOLE MAGNESIUM); RAMIPRIL (RAMIPRIL); DEPAKINE ENTERIC (VALPROATE SODIUM); TEGRETOL CR (CARBAMAZEPINE)
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 65