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On 28-mar-2024, angelini s.P.A.Provided the following case information to bridges consumer healthcare.Angelini s.P.A.First received the information on 19-mar-2024.This serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 19/mar/2024 from a pharmacist through diamed (b)(4).Follow-up information received on 27/03/2024 through diamed, the information was merged and processed together.This case report concerns a female patient (age:75 years), who applied thermacare lower back and hip (batch number: unknown; expiry date: unknown), for unknown indication.Concomitant medication(s): unknown.Medical history: unknown.On (b)(6) 2024, after thermacare lower back and hip initiation, the patient experienced burns second degree, intentional device misuse.The consumer applied thermacare heat wraps for lower back and hip.The consumer experienced burns second degree, because she applied the heat wrap for a long time on her skin nor used it during the night.On (b)(6) 2024, the 75-year-old consumer applied thermacare lbh (batch number: ga0802) for 8 hours.She applied the heat wrap directly on the skin without wearing a shirt underneath.Outcome: burns second degree : unknown intentional device misuse: unknown.The action taken in response for the event for thermacare lower back and hip was unknown.(b)(6) medical assessment: the pi of thermacare lower back and hip mentions that burns second degree could be an adverse event of this medical device, whereas it does not mention intentional device misuse.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare lower back and hip and the reported adverse event was considered as possible, for intentional device misuse it was considered not assessable.The overall assessment for this case is serious/unlabeled/possible.The anticipated date of the next report is 08-may-2024.
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On 11-apr-2204, angelini s.P.A.Provided bridges consumer healthcare additional information.Angelini s.P.A.Received the information on 01-apr-2024.The verbatim of the report is as follows: follow up 1 received on 01-apr-2024 from qa department.Complaint number: (b)(4).This complaint complies with the requirements stated in investigation procedure (b)(4) processing consumer complaints, effective 02-jan-2024 and it is recommended for approval.A 36-month trend analysis has been conducted.The trend analysis returned a total of 129 complaints for lower back and hip 8 hour products during the period 03-19-2021 to 03-19-2024 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 and hip 8 hour product.The search described in the investigation summary takes into consideration all adverse events.This search was not specific to burns only.There is no further action required.Considering the current information available for this complaint it is determined the root cause is intentional device misuse.The 75-year-old consumer applied thermacare lbh (batch number: ga0802) for 8 hours.She applied the heat wrap directly on the skin without wearing a shirt underneath.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).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.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.The product quality for the batch is not impacted by this complaint.This complaint complies with the requirements stated in investigation procedure (b)(4) processing consumer complaints, effective 02-jan-2024 and it is recommended for approval.A 36-month trend analysis has been conducted.The trend analysis returned a total of 129 complaints for lower back and hip 8 hour products during the period 03-19-2021 to 03-19-2024 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 and hip 8-hour product.The search described in the investigation summary takes into consideration all adverse events.This search was not specific to burns only.There is no further action required.Considering the current information available for this complaint it is determined the root cause is intentional device misuse.The 75-year-old consumer applied thermacare lbh (batch number: ga0802) for 8 hours.She applied the heat wrap directly on the skin without wearing a shirt underneath.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).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.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.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 rpt-000097160.During the investigation of this complaint rpt-000097160 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 second 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 intentional device misuse.The pi of thermacare lower back and hip mentions that burns second degree could be an adverse event of this medical device, whereas it does not mention intentional device misuse.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare lower back and hip and the reported adverse event was considered as possible, for intentional device misuse it was considered not assessable.Batch ga0802 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.No retain evaluation is required for this complaint, as no defect was reported.The complaint was evaluated to identify a potential trend for the batch and subclass.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare lbh 8hr products.There is no further action required.The evaluation of the batch history shows this is the first complaint for the subclass adverse event safety request for investigation.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare lbh 8hr products.There is no further action required.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.The most probable root cause is intentional device misuse.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks.The product quality for the batch is not impacted by this complaint.
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