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Pcom investigation report (b)(4) from pfizer (b)(4) for lot number t69820, expiration jul2020.Results: the visual inspection of a retain sample included one carton and the four pouched wraps inside.There were no obvious defects found on cartons, or pouched wraps.Form-(b)(4) retain sample inspection form documented the retain evaluation performed on 06-feb-2018.An evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request investigation received at the (b)(4) site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause of the complaint of adverse event.On the basis of this evaluation, 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 process 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 two wrap attribute defects recorded for the batch; wrap delamination minor, process clean up of a dead plate corrected the defect, and a dead cell (an individual cell pack not dosed with brine solution will not heat up), replacement of a brine pump corrected the defect.The corrective action procedures were followed per standard operating procedure sop-(b)(4) -product quality control cap procedure, effective date: (b)(4) 2015.Shiftly production transition notes were reviewed.There were no issues noted that would cause an adverse event.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Is there a potential quality impact that requires a notification to management? response rationale: the thermal data was reviewed and ther.
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Event verbatim [preferred term] burning signs of 2nd degree surrounding with erythema [burns second degree], bleeding wound [wound haemorrhage], inflamed wound [inflammation of wound], when thermacare was taken off, the skin came off [skin exfoliation].This is a spontaneous report from a contactable pharmacist.A (b)(6) year-old female patient of an unspecified ethnicity used thermacare heatwrap (thermacare heatwrap) on (b)(6) 2018 for lower back pain.The lot number was t69820, expiration jul2020 (pack number (b)(4)).The patient medical history and concomitant medications were not reported.Thermacare had been used in the past and was tolerated at the time.The patient stated that on (b)(6) 2018 when the thermacare wrap was taken off, the skin came off (about the size of a 2 euro coin) (end of event not in sight, slow improvement).This resulted in a bleeding wound on (b)(6) 2018 which was treated by the doctor with flamigel and a solution for cleaning.Later the inflamed wound ((b)(6) 2018) was also treated with antibiotics.The patient presented with a burn of 2nd degree with inflammatory content.Details of the burn was described as burning signs of 2nd degree surrounding with erythema.The patient received local antinflammatory treatment and oral antibiotic.It was not expected that the patient would experience long-term sequelae such as scarring.The patient did not administer any relevant medications, including topical medications, at the time of the adverse events.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events "bleeding wound" and "when thermacare was taken off, the skin came off" was resolving.The outcome of the event "inflamed wound" and "burning signs of 2nd degree surrounding with erythema" was unknown.Re-exposure if applicable was given as "negative".The reporter considered the event to be definitely related to thermacare.According to the product quality complaint group: pcom investigation report (b)(4) from pfizer (b)(4) for lot number t69820, expiration jul2020.Results: the visual inspection of a retain sample included one carton and the four pouched wraps inside.There were no obvious defects found on cartons, or pouched wraps.Form-(b)(4) retain sample inspection form documented the retain evaluation performed on 06-feb-2018.An evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request investigation received at the (b)(4) site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause of the complaint of adverse event.On the basis of this evaluation, 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 process 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 two wrap attribute defects recorded for the batch; wrap delamination minor, process clean up of a dead plate corrected the defect, and a dead cell (an individual cell pack not dosed with brine solution will not heat up), replacement of a brine pump corrected the defect.The corrective action procedures were followed per standard operating procedure sop-(b)(4)-product quality control cap procedure, effective date: (b)(4) 2015.Shiftly production transition notes were reviewed.There were no issues noted that would cause an adverse event.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Is there a potential quality impact that requires a notification to management? response rationale: the thermal data was reviewed and there were no thermal results outside the required specifications.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.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 batch records, release testing data 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.The events ["burning signs of 2nd degree surrounding with erythema", "bleeding wound", "when thermacare was taken off, the skin came off" and "inflamed wound"] occurred in a country different from that of the reporter.This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.Additional information has been requested and will be provided as it becomes available.Follow-up (13feb2018): new information received from the product quality complaint group included investigational results.Follow-up (16mar2018): new information received from a physician (new added) included: new events (burning signs of 2nd degree surrounding with erythema), treatment received and case updated to reportable.Follow-up attempts completed.No further information expected.Company clinical evaluation comment: based on the information provided, the events of "burns second degree" "wound bleeding", "inflammation of wound" and "exfoliation of skin" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of "burns second degree" "wound bleeding", "inflammation of wound" and "exfoliation of skin" as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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