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

Lot Number J36111

Device Problems Improper or Incorrect Procedure or Method (2017); Defective Device (2588)

Patient Problems Abdominal Pain (1685); Peeling (1999); Burn, Thermal (2530)

Event Date 04/22/2015

Event Type  Other  

Event Description

Burnt/ burnt the hell out of her/ burn was bigger than a 50 percent/wrap burned the hell out of her stomach/it burns [thermal burn], wore the skin off of her/ skin was gone/ skin was missing/the skin was not there [skin exfoliation], terrible pain in her stomach [abdominal pain upper], it hurts bad/ it was hurting [pain], she did not use the wrap over healthy skin [device misuse], could not feel it as it was not hot/she could not feel it [product quality issue].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back and hip) (lot#: j36111, expiration date: sep2017) on (b)(6) 2015, used the other one on (b)(6) 2015 for menstrual cramps.The patient was allergic to nickel.The patient's concomitant medications include ibuprofen for cramps.Consumer stated that she had question about thermacare heat wrap.She had used them many times and she gets terrible pain in her stomach and this wrap burnt her on (b)(6) 2015.She could not feel it as it was not hot.The heat wrap had only plastic over it and she had not covered it with anything but this thermacare wore the skin off of her and it hurts bad.It burnt the hell out of her.She did not know if it was burning her until she took it off and the skin was gone.The consumer mentioned that the burn was bigger than a 50 percent and it was on her stomach and there was no drainage of pus from the burn.She mentioned that it was hurting and the skin was missing.Her skin tone: light.She did not use any cream, rubs or gel under the wrap.There was no defect on the wrap like cuts, tears, leaks or holes.She did not put the wrap in the microwave.There was no change in the color of the wrap.She did not exercise while using the wrap.Wrap was not changed or modified in anyway.She did not use the wrap overnight or while sleeping.She did not use the wrap over healthy skin.The patient mentioned the pad applied to skin over lower stomach for 4 hours.There was no pain from the thermacare.It felt warm, but not hot.The patient states she noted the issue when she went to remove the thermacare after four hours.Describes an area on the left side of her stomach that is an inch or two wide and a couple inches long where the skin was just gone.It was like she rubbed it when removing the thermacare and the skin was not there.States there is no moisture, but it burns.There was a welt surrounding the area that is now resolved.The welt was a lot wider than where the skin was missing.The patient stopped using the heatwrap.She was not seen by a physician to evaluate or treat the area.States she used no creams.States she put a bandaid over it or let it breathe.States she used a bandage to cover it as the area rubs on her pants and makes her want to cry.The welts around the area where the skin is missing went away, but the rest is still there.She thinks it is healing, but the scab keeps breaking open.Additional information has been requested and will be provided as it becomes available.

Manufacturer Narrative

Follow-up (27apr2015): new information received from contactable consumer including patient age and ethnicity updated.Suspect drug updated to thermacare lower back and hip, indication added.Drug start date and event onset date added.Pt medical history and concomitant medications added.The detail of event description added.Follow-up (29apr2015): new information received from a contactable consumer includes: lot number and expiration date.Follow up (27apr2015): this report is being submitted as a serious, reportable medical device report and to update the company receipt date in the narrative from 28apr2015 to 27 apr2015.Company clinical evaluation comment based on the information provided, the events device misuse, thermal burn, wore the skin off of her/ skin was gone, abdominal pain upper, and pain as described in this case represent 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.This case meets initial 10-day eu and 30-day fda reportability.

Manufacturer Narrative

Investigation 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 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.Process not related.Complaint not confirmed.Follow up (06/19/2015): follow-up attempts complete.No further information expected.Follow up (06/24/2015).New information received from product quality complaint group included: product investigation result.Follow-up attempts completed.No further information expected.

• 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 drive; albany GA 31705
• Manufacturer Contact: 1231 wyandotte drive; albany, GA 31705 ; 2127335544
• MDR Report Key: 4769032
• MDR Text Key: 5778641
• Report Number: 1066015-2015-00048
• 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,consumer
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

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: 09/01/2017
• Device Lot Number: J36111
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• 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: 35 YR
• Patient Weight: 82