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Preliminary results and conclusions of manufacturer's investigation: reportable unanticipated serious deterioration in state of health incident identified.Investigation is in progress.The anticipated date for the follow up report is 13-aug-2021.This investigation was conducted for an unknown thermacare product.There was limited device specific information provided.No batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Per (b)(4), complaint trending guideline, effective date: 29-apr-2021, in section 3.2.1, the complaints were evaluated to identify any potential trends.The trackwise digital (twd) complaint search was performed for product description listed as thermacare.No specific product description (i.E., thermacare lower back and hip, thermacare flexible use xl, thermacare neck shoulder and wrist, etc.) was provided at intake.Complaint investigations were previously handled in the legacy quality tracking system (qts) until 14-mar-2021 and included a specific product description for all complaint records handled in the system.As a result, the scope of search includes trackwise digital (twd) complaint with date contacted beginning on 15-mar-2021 (the implementation date of twd complaints).The twd search includes a product description of "thermacare" since there is not a specific product description provided.The following trackwise digital (twd) complaints search was performed: twd complaints scope: date contacted: 15-mar-2021 through 24-jun-2021 manufacturing site: angelini albany / complaint class: undesirable side effect / complaint sub class: /adverse event safety request for investigation the twd search returned a total of one complaint for thermacare products during this time period for the class/subclass.It was not confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation based on this twd search, the data did not show an increase over time.There is not a trend identified for the subclass adverse event safety request for investigation for thermacare products, refer to the attached trending chart adverse event safety request for investigation thermacare.There is no further action required.Capa required: no.Root cause investigation required: no.On 12-jul-2021, angelini s.P.A.Provided bridges consumer healthcare with additional information which they received on 02-jul-2021 and 06-jul-2021.The verbatim of the additional information was as follows: additional information was received via phone call of the patient on 02-jul-2021 and on 06-jul-2021.The patient was (b)(6)-year-old.Initially (on 24-jun-2021) the patient reported three hours of use, later (on (b)(6) 2021) the patient stated approximately 1.5 hours of use, which led to the patient suffering severe burns classified as second and third degree.The heat wrap was applied directly onto the skin.No prior skin diseases were known.The patient claimed years of experience with thermacare.The patient also experienced pain which was still present on (b)(6) 2021.The burns led the patient to seek medical attention, where she received an ointment and bandage for the wound.The burn left her unable to work for one week.The batch number was unknown as the patient disposed of the package.The patient had not yet recovered.Based on the information provided, the events burns second degree, burns third degree and pain as described in this case are 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 heat wraps does not mention that burns second degree, burns third degree and pain 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 heat wraps and events is considered as possible.This investigation was conducted for an unknown thermacare product.There was limited device specific information provided.No batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Based on this twd search, the data did not show an increase over time.There is not a trend identified for the subclass adverse event safety request for investigation for thermacare products, refer to the attached trending chart adverse event safety request for investigation thermacare.There is no further action required.
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On 02-jul-2021, angelini s.P.A.Provided bridges consumer healthcare the following report which they received on 24-juin-2021.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from (b)(6) received on 24-jun-2021 from a pharmacist through diamed (de1425).This case report concerns a female patient with no relevant medical history, who applied thermacare heat wraps via topical route for unknown indication, in the year 2021.Concomitant medication(s): not reported.On unknown date in 2021, after thermacare heat wraps (waermeauflagen) initiation, the patient developed burns second degree, burns third degree.After three hours of use the patient suffered burns classified as second and third degree.It is unknown if any action was taken with the thermacare heat wrap.Relevant laboratory test results include: not reported.Outcome: burns second degree : unknown, burns third degree : unknown.The reporter assessed this report as serious and didn't provide causal relationship to thermacare waermeauflagen.
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