MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE LOWER BACK & HIP; HOT OR COLD DISPOSABLE PACK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Superficial (First Degree) Burn (2685); Blister (4537)

Event Date 10/06/2023

Event Type  Injury  

Event Description

This serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 10/oct/2023 from a pharmacist through (b)(6).This case report concerns a 71-years-old female patient (height 1.53 m, weight 81 kg), who applied thermacare lower back and hip (batch number ga0581; expiry date was unknown) for back discomfort.Concomitant medication(s): thyroid medication.Medical history was unknown.On (b)(6) 2023, approximately at 10 o'clock, after thermacare lower back and hip initiation, the patient experienced thermal burn, blister.The patient applied a thermacare heat wrap and after application she noticed mild burns, and blisters upon removal of the heat wrap in the early evening at the application site.Further information was not available at the time of this report.Outcome: thermal burn: unknown, blister : unknown.The action taken for thermacare lower back and hip was unknown.The anticipated date of the next report is 29-nov-2023.

Manufacturer Narrative

Reportable near incident identified investigation in progress.

Manufacturer Narrative

On 31-oct-2023, bridges consumer healthcare received additional information was received from angelini.The verbatim of the information follows: follow-up received on 25/oct/2023 form qa department.Complaint number was (b)(4).Batch #: ga0581.Batch code/sku#: f00573301023w.Product count: 2 count.Date of manufacture: 25-jul-2022 to 26-jul-2022.Expiry date: 06-30-2025.Quantity released: (b)(4).A 36-month trend analysis has been conducted.The trend analysis returned a total of (b)(4) complaints for lower back/hip (lbh) heat wrap 8 hr products during the period 10-11-2020 to 10-11-2023 for the class/subclass.None of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this trend analysis, the data did not show an increase over time.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare lower back hip product.There is no further action required.Considering the current information available for this complaint it is not possible to determine a root cause.However, there are pre-identified risk factors that could cause a burn listed in the hazard analysis ((b)(4)).There are mitigations in place to prevent these situations such as in-process testing, thermal testing and visual inspections to ensure the quality and safety of the product.There are also 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.There are pre-identified risk factors that could cause skin irritation 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 events of thermal burn and blisters as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The pi of thermacare lower back and hip mentions that thermal burn and blisters could be adverse events of this medical device.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare lower back and hip and the events is considered as possible.Batch ga0581 is the only batch within the scope of this investigation.The device history record, manufacturing electronic system records, retain samples, thermal results, raw materials and trending were evaluated.No quality issues were identified during the production of the batch.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects to carton or pouched wraps.The complaint was evaluated to identify a potential trend for the lot and subclass.A trend does not exist for this batch.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in processing inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.There were no wrap attribute or variable defects recorded for the batch.Considering the current information available for this complaint it is not possible to determine a root cause.

• Brand Name: THERMACARE LOWER BACK & HIP
• Type of Device: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street; suite 600; chattanogga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; albany, GA 31705 ; 4237178579
• MDR Report Key: 17990561
• MDR Text Key: 326357186
• Report Number: 3007593958-2023-00066
• 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: 11/02/2023

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
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/02/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 81 KG