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

Lot Number W91244

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

The root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "i noticed that there are marks on her back from the thermacare." the cause of the marks are inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 13th complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse events safety request for investigation.

Event Description

I noticed that there are marks on her back from the thermacare/there is a dark mark in the middle of her back [skin discolouration], it made a burnt on my mother's back [thermal burn], skin irritation [skin irritation].Case narrative: this is a spontaneous report from a contactable consumer reported for mother.An (b)(6) female patient started to receive thermacare heatwrap (thermacare lower back & hip), device lot number w91244, expiration date jul-2021, upc/udi number (b)(4), from an unspecified date to 2019 for over a year at unknown frequency for severe back pain.Medical history was none.There were no concomitant medications.The reporter stated that because the patient had severe back pain when she used to work and then they recommended to try the thermacare so that was why she was using it.The patient had been using the thermacare for a good while and the reporter noticed that there were marks on her back from the thermacare.So the reporter took her to the doctor so the doctor told her to stop it immediately, it was the middle of her back for the relief, there was a dark mark in the middle of her back.The thermacare lower back & hip heatwrap was taken over the counter.There was no medical intervention, just for the back.No treatment received for the dark mark, they just noticed it and the reporter took her to the doctor and did not really see it and was like shoot because the reporter took over so doctor said to stop it immediately.They did not have the wrap and just got the empty box.The reporter further stated that it made a burnt on the patient's back.She had skin irritation because, they said they could use light on the skin and on the skin the reporter happened to look on the skin was really (incomplete sentence) so, her doctor said she needed to stop that immediately.So, she stopped that may be 3 or 4 months ago in 2019.The action taken in response to the events for thermacare heatwrap was permanently withdrawn in 2019.The outcome of the events was unknown.According to the product quality complaint group: site sample status: not received.Manufacturing site conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports"i noticed that there are marks on her back from the thermacare." the cause of the marks are inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing 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.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the 13th complaint for the sub class adverse event safety request for investigation received at the (b)(4) site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this batch.Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.Based on this citi search, there is not a trend identified for the subclass of adverse events safety request for investigation.Dchu conclusion: based on the complaint narrative, the patient sustained a dark mark on the body where the product was placed.Review of complaint description concludes there is no device malfunction.Severity of harm was s3 for complaint sub-class: adverse event/serious/unknown.Follow-up (19-jul-2019): new information received from the product quality complaint group includes: product information (updated expiration date), and product investigation summary results.Follow-up (19-jul2-019, 26-sep-2019 and 20-nov-2019): new information received from the product quality complaint group and a contactable consumer includes severity rating, investigational results from dchu, case upgraded to serious, malfunction reportable mdr and device data (updated expiration date and stop date of the device), new event (it made a burnt on my mother's back/skin irritation).Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events skin discolouration, thermal burn and skin irritation 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events skin discolouration, thermal burn and skin irritation 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.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.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: 9444782
• MDR Text Key: 188390485
• Report Number: 1066015-2019-00527
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 305733010037
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2021
• Device Lot Number: W91244
• Was Device Available for Evaluation?: No
• 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: 87 YR
• Patient Weight: 59