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

Lot Number DP0466

Device Problems Therapeutic or Diagnostic Output Failure (3023); Excessive Heating (4030)

Patient Problems Pain (1994); Rash (2033); Skin Burning Sensation (4540)

Event Date 03/08/2021

Event Type  malfunction  

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 the wrap "just felt too hot." the cause of the consumer stating the wrap "just felt too hot" is inconclusive since review of records does not provide evidence to support defective product.Care should be taken when using the device, following all safety and use information as provided with the wrap.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.

Event Description

Event verbatim [preferred term] her back felt like it was on fire/has a little burning [burning sensation], a little blotchy [rash macular], felt too hot [device issue], still has a lot of back pain [device ineffective], narrative: this is a spontaneous report from a contactable consumer (patient).A (b)(6) female patient received thermacare heatwrap (thermacare lower back & hip), device lot number dp0466, expiration date feb2023, upc/udi number (b)(4), on (b)(6) 2021 at as needed for back pain.Medical history was none.There were no concomitant medications.On (b)(6) 2021, the patient wore thermacare for the back over clothes and her back felt like it was on fire.She wore it for four hours but there was no redness it just felt too hot then she took it off.She was using thermacare today ((b)(6) 2021) for the first time.She was going back to work and still had a lot of back pain on (b)(6) 2021.She thought it would help her since she only worked in the morning but she couldn't keep it on the full time.She still had a little burning; it was not red but it was a little blotchy but she only just took it off on (b)(6) 2021.She added taking the product off made it feel better.She was just calling to see if she could put ice on it? she still had one unused wrap.Packaging was sealed and intact.Device was available for evaluation.Action taken with the thermacare heatwrap in response to the events was permanently discontinued on (b)(6) 2021.The outcome of the event still has a lot of back pain was unknown and the outcome of the other events was resolving.The reporter considered that there was a reasonable possibility that the event felt too hot was related to the device.According to the product quality complaint group: 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 the wrap "just felt too hot." the cause of the consumer stating the wrap "just felt too hot" is inconclusive since review of records does not provide evidence to support defective product.Care should be taken when using the device, following all safety and use information as provided with the wrap.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.No follow-up attempts are needed.No further information is expected.

• 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
• MDR Report Key: 11555576
• MDR Text Key: 280476548
• Report Number: 1066015-2021-00040
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010037
• UDI-Public: 305733010037
• 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: 03/08/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2023
• Device Lot Number: DP0466
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 72