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On 24-nov-2023, 27-nov-2023 and 28-nov-2023, bridges consumer healthcare received the following report from angelini s.P.A.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from switzerland received on 14/nov/2023 from a consumer through verfora (md23-14).Follow-up information received on 16/nov/2023 and the one recived on 20/nov/2023 through verfora, the information was merged and processed together.This case report concerns a female patient (age not reported), who applied thermacare menstrual pain (batch number: ga0798 expiration date: 09/30/2025) for unknown indication.Concomitant medications: past use of thermacare menstrual.Medical history: unknown on (b)(6) 2023, after thermacare menstrual pain initiation, the patient complained about thermal burn, skin exfoliation.The consumer reported that she had been using thermacare menstrual patches for a long time and had always been very satisfied with the effect.After a few hours of application, she discovered a burn on her abdomen and part of the skin even peeled off.The burn was noticed by the consumer after about 4 hours.The consumer also stated that she applied the patch in her underwear and not directly on her skin.She did not sunbathe and did not use any body lotion.Outcome: thermal burn : unknown, skin exfoliation : unknown.The action taken in response for the events thermacare menstrual pain was unknown.Angelini medical assessment: the pi of thermacare menstrual pain mentions that thermal burn and skin exfoliation 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 menstrual pain 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 03-jan-2024.
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On 18-dec-2023 (b)(6)
provided additional information regarding the case to bridges consumer healthcare.On 06-dec-2023, angelni s.P.A.Received the information.Follow up received on 06/dec/2023 from qa department.Complaint number (b)(4).Batch #: ga0798.Batch code/sku#: f00573302020p.Product count: 2 count.Date of manufacture: 21-feb-2023 to 22-feb-2023.Expiry date: 01-31-2026.Quantity released: (b)(4).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 30 complaints for the menstrual 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 menstrual 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 burns listed in the hazard analysis ((b)(4)).During the investigation of this complaint (b)(4) was reviewed an (b)(4).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 skin exfoliation 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 menstrual pain mentions that thermal burn and skin exfoliation 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 menstrual pain and the reported adverse events was considered as possible.Batch ga0798 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.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.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.
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