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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Caustic/Chemical Burns (2549)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed as a quality defect).Since there was no batch number or return sample available for evaluation, there was limited device specific information provided to evaluate.A batch reference number and/or return sample is needed to complete a manufacturing and technical evaluation for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event safety request for investigation with the product type of lower back and hip (lbh) products.The manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection to ensure the quality of the product being packaged.

Event Description

Event verbatim [preferred term] used it on her leg and got a chemical burn/there were 2 red spots, but only one spot that actually scabbed over [chemical burn of skin], kept in on overnight for leg pain/ used the product her leg [device use error].Case narrative: this is a spontaneous report from a contactable consumer reporting for herself.A (b)(6)-year-old non-pregnant female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number unavailable) from (b)(6) 2018 to (b)(6) 2018 at 1 heatwrap and kept in on overnight for leg pain after an injury.The patient's medical history included injury, sensitive skin, post-menopausal and hysterectomy.There were no concomitant medications.The reporter stated she used the product her leg and it caused a chemical burn on (b)(6) 2018.She said that she saw the recall and thought she better let us know.She did not have a physician to provide.It left a mark on her skin and did not burn anymore.After she used it, she could see the circles from it and when she took a bath she could feel it even more.Now it was scabbed over.She said that there were 2 red spots, but only one spot that actually scabbed over.They were about the size of the heat cells.The heatwraps were in a red box and she said that she had used thermacare before.She said that they were the l/xl size.She did not do anything to treat the area, she was just letting it heal on it's own.Additional seriousness criteria: none.The patient considered there was a reasonable possibility that an ae is related to the device.The patient was not currently under the care of a physician for any medical condition.She classified her skin tone as medium and denied having abnormal skin conditions.She said 1 day in a row that thermacare was used and number of hours per day that thermacare was used: 8-9 hours at the most.Action taken for the product was permanently withdrawn on (b)(6) 2018.The outcome of the event used it on her leg and got a chemical burn/there were 2 red spots, but only one spot that actually scabbed over was resolving.The outcome of other event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed as a quality defect).Since there was no batch number or return sample available for evaluation, there was limited device specific information provided to evaluate.A batch reference number and/or return sample is needed to complete a manufacturing and technical evaluation for the wrap involved in this case.There is not a product quality related trend identified for the subclass of adverse event safety request for investigation with the product type of lower back and hip (lbh) products.The manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection to ensure the quality of the product being packaged.Additional information has been requested and will be provided as it becomes available.Follow-up ((b)(4) 2018): this follow-up report is being submitted as a reportable mdr.Follow-up (12apr2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events of "chemical burn and device use error" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.In the case narrative, there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events of "chemical burn and device use error" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.In the case narrative, there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• Manufacturer Contact: stella pietrafesa ; 235 e42nd street; new york, NY 10017
• MDR Report Key: 8529633
• MDR Text Key: 142467682
• Report Number: 1066015-2019-00115
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2018

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 47