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Bridges consumer healthcare received the following case on 22-dec-2021 from angelini (b)(6).(b)(4) (b)(6) first received the case on 10-dec-2021.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) (internal id (b)(4)) is an initial report from (b)(6) received on 10-dec-2021 from a patient.Follow-up information received from the reporter on 14-dec-2021.The information was merged and processed together.This case report concerns a female patient (age unknown) who applied thermacare lower back and hip (batch number and expiry date unknown) for unknown indication.Medical history and concomitant medications were not reported.On unknown date after thermacare lower back and hip initiation the patient experienced burning skin, blister and pruritus.According to the patient, she was well and already recovered from the reported event.From the conversation, it was communicated that: it was the first time she used thermacare.She does not know batch or any other reference to the product.She reported that about 2 hours after application she felt local heat and burning on site, so she immediately removed the product.At the time, she did not mention any other cutaneous manifestation.About 24 hours later, she reports the appearance of some "bubbles" in the area, with itching and the skin integrates between the "bubbles".She went to a pharmacy and was suggested to apply "biaffine" on the spot due to a potential suspicion of burn.As she did not see any improvement with biafine, she applied corticosteroid ointment with rapid improvement.She spontaneously mentions that she thinks it was an allergic reaction.In addition to going to the pharmacy, she did not consult any other health professional.Outcome: burning skin, recovered/resolved, blister, recovered/resolved, pruritus: recovered/resolved.The action taken in response to the events for thermacare lower back and hip was reported in device discontinuation.
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Manufacturer narrative: on 10-dec-2021: reportable near incident identified.Investigation in progress.On 21-dec-2021, (b)(4) received additional information.On 31-dec-2021, bridges consumer healthcare received the additional information from angelini s.P.A.Follow up received on 21-dec-2021 from qa department.Complaint number: (b)(4).This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Limited device specific information provided, and no batch number was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search performed: citi scope: date contacted: 12/10/2018 through 03/14/2021 / manufacturing site: pfizer (b)(6)/complaint class: external cause investigation/complaint sub class: adverse event safety request for investigation.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Limited device specific information provided, and no batch number was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search performed: citi scope: date contacted: 12/10/2018 through 03/14/2021 / manufacturing site: pfizer (b)(6)/complaint class: external cause investigation/complaint sub class: adverse event safety request for investigation.Twd scope: date contacted: 03/15/2021 through 12/10/2021 / manufacturing site: (b)(4) (b)(6) / complaint class: undesirable side effect / adverse event safety request for investigation.The citi customizable and twd search returned a total of 465 complaints for lower back/hip (lbh) products during this period 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.The data shows a seasonality increase in december 2018.The data shows a gradual increase starting in march 2019 and april 2019, with a spike in may 2019.Forty-nine of the 76, complaints received in april 2019 were related to too cool, heat/cold did not last long enough, never worked, primary container package damaged/defect not classified.Ninety-eight of the 159 complaints in may 2019 were related to too cool, heat/cold did not last long enough, never worked, primary container package damaged/defect not classified.Complaints related to too cool, heat/cold did not last long enough, never worked, primary container package damaged/defect not classified have a severity ranking of minor, inconvenient, with no harm per (b)(4) hazard analysis, thermacare heat wrap product: 8 and 12hr, approved 05-oct-2021.March 2019 through may 2019 shows an increase attributed to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473, and w37940 from april 2019.According to rpt-000097160, hazard analysis, thermacare heat wrap product: 8 and 12hr, approved 05-oct-2021, section 10.3 - consumer complaints, in april 2019, (b)(4) initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower back, and hip include s97473 (us), s00639 ((b)(6)), s23902 ((b)(6)), and w37940 ((b)(6)).The recall action taken after the batches were released with an out of specification result for high-temperature cell(s), and no product isolation of impacted product performed.The release of these batches without product isolation is a compliance gap.The manufacturing investigation (pr 3938189, legacy qts, closed 04-sep-2019) resulted in corrective actions, including improving procedures for containing and investigating the nonconforming product.Based on this customizable citi and twd search, a trend does not exist for the subclass adverse event safety request for investigation for lbh 8hr products.No further action is required.Based on the information provided, the events burning skin, blister and pruritus 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 lower back and hip mention that burning skin and blister could be adverse events of this medical device, whereas it does not mention pruritus as adverse event.Dechallenge and rechallenge were not applicable.Temporal association adverse events-medical device is plausible.Based on the information provided the causal relationship between thermacare lower back and hip and incident is considered as possible.This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.Limited device specific information provided, and no batch number was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.A complaint intake, triage, and investigation (citi) customizable search and a trackwise digital (twd) complaints search performed.Based on this customizable citi and twd search, a trend does not exist for the subclass adverse event.No further action is required.
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