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

Lot Number GA0163

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

Patient Problems Burning Sensation (2146); Superficial (First Degree) Burn (2685)

Event Type  Injury  

Manufacturer Narrative

Reportable near incidents identified.Investigation in progress.

Event Description

On 21-dec-2023, angelini s.P.A.Provided bridges consumer healthcare with the following case.Angelini s.P.A.Received the case on 13-dec-2023.The report verbatim is as follows: this serious spontaneous case, manufacturer control number 2023-032902 is an initial report from italy received on 12/dec/2023 from a consumer/other non health professional through italymdvigilance via customer service (5104371).Follow up information received on 13/dec/2023 reagrding batch number and follow up information received on 14/dec/2023 regarding patient information (sex and age) was merged with initial and processed together.This case report concerns a female patien (48 years old)t, who applied thermacare neck/ shoulder/wrist (batch number was ga0163; expiry date was 31/jul/2023) for cervical pain.Concomitant medication (s):unknown.Medical history:uknown.On unknown date after thermacare neck/shoulder/wrist initiation, the patient experienced thermal burn, burning.The consumer reported that after a few hours, upon removal, she felta strong burning sensation.Initially, she did not think much of it, but when she noticed the growing discomfort she discovered that, on one of the two sides, the patch had left a noticeable burn on the skin (attach photo documentation).The consumer also reported that at the time of this report she has a scab and hopes it will not remain a scar.The consumer stadet that she considered the incident serious and wanted to bring it to attention.She reported that she was aware of how the patch should have been worn and used.Outcome: thermal burn : not recovered/not resolved, burning : not recovered/not resolved 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 and burning could be adverse events of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare neck/shoulder/wrist and the reported adverse events was considered as possible.The overall assessment for this case is serious/labeled/possible.The anticipated date of the next report is 31-jan-2024.

Manufacturer Narrative

Angelini s.P.A.Provided bridges consumer healthcare with the following additional information for this report on 17-jan-2024.Angelini s.P.A.Received the additional information on 08-jan-2024.The report verbatim is as follows: follow-up received on 08/jan/2024 from qa department.Complaint number (b)(4): batch code#: ga0163.Product count: 6 count.Brand code/sku#: f00573301528w.Date of manufacture: 26-aug-2021 through 28-aug-2021.Expiry date: 07-31-2024.Quantity released: (b)(4) cartons.A 36-month trend analysis has been conducted.The trend analysis returned a total of 34 complaints for neck shoulder wrist 8 hour products during the period 12-12-2020 to 12-12-2023 for the class/subclass.(four of the 34 were not identified as 8 or 12 hour product.) 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 neck shoulder wrist 8 hour 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/blister listed in the hazard analysis (b)(4).There are mitigations in place to prevent these situations such as inprocess 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.All materials used in the production of this batch were inspected and released by quality control before being released for use.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 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 burn thermal burn and burning 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/ mentions that thermal burn and burning could be adverse events of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare neck/shoulder/wrist and the reported adverse events was considered as possible.The overall assessment for this case is serious/labeled/possible.Batch ga0163 is the only batch within the scope of this investigation.The device history record, manufacturing electronic system records, thermal results, raw materials and trending were evaluated.No quality issues were identified during the production of the batch.No retain evaluation was required for this complaint.The complaint was evaluated to identify a potential trend for the subclass and product type.There is not a trend identified.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 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.This complaint is not justified and no issues were found during batch/production data review to suggest the adverse event was related to a product defect.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
• Type of Device: HOT OR COLD DISPOSABLE PACK
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street; suite 600; chattanooga TN
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18399948
• MDR Text Key: 331412460
• Report Number: 3007593958-2023-00086
• 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: 01/18/2024

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 Expiration Date: 07/31/2023
• Device Lot Number: GA0163
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/19/2024
• 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: 48 YR
• Patient Sex: Female