MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE NECK/SHOULDER/WRIST 8HR; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0330

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

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

Reportable near incident identified investigation in progress.

Event Description

On 28-nov-2023, bridges consumer healthcare received the following report from angelini s.P.A who received the report on 17-nov-2023.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from italy received on 17/nov/2023 from a consumer/other non-health professional through italy mdvigilance via customer service ((b)(4)).This case report concerns a patient (gender and age was unknown) , who applied thermacare neck shoulder wrist for unknown indication, concomitant medication(s) and medical history was unknown.On unknown date after thermacare neck shoulder wrist initiation, the patient experienced thermal burn.The consumer, after 5 days of using thermacare, got burns on her neck.She never exceeded 8 hours a day.Outcome: thermal burn : unknown.The action taken in response for the event to thermacare neck shoulder wrist was unknown.Angelini medical assessment: the pi of thermacare neck shoulder wrist mentions that thermal burn could be an adverse event of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse event-medical device is plausible.Based on the information provided, the causal relationship between thermacare neck shoulder wrist and the reported adverse event was considered as possible.The overall assessment for this case is serious/labeled/possible the anticipated date of the next report is 06-jan-2024.

Manufacturer Narrative

On (b)(6) 2023 and on (b)(6) 2023, (b)(6).Provided additional information regarding the case to bridges consumer healthcare.(b)(6) received the information on (b)(6)2023.Follow up received on 05/dec/2023 from qa department.Complaint number (b)(4) : batch code: ga0330 product count: 6 count brand code/sku: f00573301528w date of manufacture: 30-nov-2021 to 01-dec-2021 expiry date: 10-31-2024 quantity released: (b)(4) cartons.A 36-month trend analysis has been conducted for subclass adverse event safety request investigation complaints including known and unknown lot numbers.The records search returned a total of 31 complaints for the nsw 8hr products during this time period, for the subclass for all adverse events (including burns).There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation.Based on this search, 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 nsw 8hr 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.Is root cause confirmed? no has the risk assessment been reviewed? no.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 thermal burn 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 neck shoulder wrist mentions that thermal burn could be an adverse event of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse event-medical device is plausible.Based on the information provided, the causal relationship between thermacare neck shoulder wrist and the reported adverse event was considered as possible.Batch ga0330 is the only batch within the scope of this investigation.The device history record (dhr), retain samples, thermal results and trending were evaluated.The visual inspection of a retain sample for batch ga0330 included one carton and the six pouched wraps inside and shows no obvious defects.An evaluation of the complaint history confirms that this is the first complaint for the sub-class adverse event safety request for investigation received and requiring an evaluation of this batch.The complaint was evaluated to identify any potential trend for the lot and subclass.A trend was not identified.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attribute and variable quality checks associated with this batch indicate 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.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.No quality issues were identified upon the 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.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 8HR
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street; suite 600; chattanooga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr, albany, ga; albany GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18310891
• MDR Text Key: 330284218
• Report Number: 3007593958-2023-00075
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/19/2023

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: GA0330
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/22/2023
• 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 Sex: Female