MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK AND HIP 8HR HEAT WRAP; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0288

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

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/15/2023

Event Type  Injury  

Event Description

(b)(4) received the following spontaneous report from germany on (b)(6) 2023.(b)(4) provided bridges consumer healthcare the report on (b)(6) 2023.This serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on (b)(6) 2023 from a consumer/other non-health professional through diamed ((b)(4)).Additional information was received on (b)(6) 2023 regarding age, duration and date of administration.The information was merged and processed together.This case report concerns a male patient (age not reported), who applied thermacare heat wraps (batch number ga0288, expiry date unknown) used for unknown indication, concomitant medications and medical history were not reported.On (b)(6) 2023 after thermacare heat wraps initiation, the patient experienced burns third degree on his lower back.According to the consumer, he applied the patch in the morning and removed it after his return (less than 8 hours).The adult male patient (age above 60 years) administered the heat wrap on (b)(6) 2023 for 7 hours.He stated to have worn it according to instruction on top of a shirt.He was treating his injuries with ointment and the healing process was going well.Outcome: burns third degree: recovering/resolving.The action taken in response to the events for thermacare heat wraps was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The expected date of the next report is (b)(6) 2023.

Manufacturer Narrative

On 18-may-2023, bridges consumer healthcare received additional information from angelini s.P.A.Which received it on 05-may-2023.Follow-up received on 05-may-2023 from qa department.Complaint number (b)(4): batch #: ga0288.Batch code/sku#: (b)(4).Product count: (b)(4).Date of manufacture: 01-nov-2021 to 05-nov-2021.Expiry date: 10-31-2024 quantity released: (b)(4).Batch ga0288 is the only batch within the scope of this investigation.Thermacare batches are produced as individuals lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports she "suffered from third degree burns".The cause of the consumer stating she "suffered from third degree burns" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of burns, blisters and skin irritations.To determine a most probable root cause, there are predetermined risk factors that could cause a burn listed in the hazard analysis (b)(4).In addition to these hazards, there are multiple risks that are outside the control of the site.These include things like age, skin condition, medical conditions, device use error and off-label use.The warning labels on our product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.Our 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks 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.The warning labels on our product report the appropriate instructions for use to our customers to avoid burns.This complaint was subject to review in order to identify any potential trends.A 36-month trend analysis was conducted for complaints.The search returned a total of (b)(4) for lower back/hip (lbh) 8 hr products during this time period for the class/subclass.None were confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation (including burns).The search did not show an increase over time for 36-months.There is not a trend identified for the subclasses of adverse event safety request for investigation for lower back/hip (lbh) 8 hr products.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (b)(4).During the investigation of this complaint (b)(4) was reviewed and no further risk was identified.Since this complaint is not justified and there is no identified defect, there is no change needed to the risk documentation as a result of this investigation.Based on the information provided, the event of burns third degree as described in this case is considered 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.The pi of thermacare heat wraps mentions that burns third degree could be an adverse event of this medical device.Temporal association adverse events-medical device is plausible.Based on the information provided the causal relationship between thermacare heat wrap and adverse event is considered as possible.Batch ga0288 is the only batch within the scope of this investigation.The device history record, reserve samples, and trending were evaluated.No quality issues were identified.The visual inspection of a retain sample included one carton with two pouched wraps inside, and shows no obvious defects to pouched wraps.An evaluation of the complaint history confirms that this is the first complaint received requiring an evaluation of this batch.A trend does not exist for this lot.Review of the batch device history record for this batch 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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperature.The most probable root cause for this complaint cannot be identified.

• Brand Name: THERMACARE LOWER BACK AND HIP 8HR HEAT WRAP
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4237178579
• MDR Report Key: 16550052
• MDR Text Key: 311368456
• Report Number: 3007593958-2023-00014
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

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 Lot Number: GA0288
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male