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Event verbatim [preferred term] blisters occured on the body due to excessive heat and usage during night [burns second degree] , excessive heat [device issue] , usage during the night [device use error].Case narrative:this is a spontaneous report from a contactable consumer or other non hcp through pch product manager.A female patient approximately (b)(6) of an unspecified ethnicity started to use thermacare heatwrap (thermacare lower back & hip) for an unspecified indication 3 or 4 years prior to pfizer receipt date of the case.The patient's medical history and concomitant medication were not reported.The patient's relative brought thermacare lower back & hip from (b)(6).On an unspecified date, the patient reported blisters occurred on the body due to excessive heat and usage during night.Action taken in response to the events for thermacare heatwrap was unknown.The patient did not have the box for the product because she used the product 3 or 4 years prior.Clinical outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the reported events burn blister, device issue, and device use error as described in this case are considered serious bodily injuries potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.
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This investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).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.The 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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation as well as the subclass wrap/patch/pad too hot.
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Event verbatim [preferred term] heat allergy [temperature intolerance], itching in lumbar region/ the patient checked application area for itching and noticed swelling [application site pruritus], swelling in lumbar region/ swelling was occurred on area where the product was stuck/ the patient checked application area for itching and noticed swelling [application site swelling], excessive heat/ thermacare lower back & hip was very hot [device issue], usage during the night/she read the usage instructions for thermacare prior to device usage [intentional device misuse].Narrative: this is a spontaneous report from a contactable pharmacist (patient) through pch product manager.This female patient (reported as "48 to 50 years old"), started to use thermacare heatwrap (thermacare lower back & hip) for low back pain 3 or 4 years ago.The product was not in the country turkey at that time, but one of the pharmacist's relatives brought the product from brussels.The patient's medical history and concomitant medication were not reported.She previously took panaheat and she thought that it gave less heat than thermacare.The patient previously took thermacare lower back & hip many times without any problem.On an unspecified date (reported as 3 or 4 years ago), the patient confirmed she experienced swelling and itching at the lumbar region and thought it was a heat allergy (previously reported as blisters occurred on the body due to excessive heat and usage during night, burning or redness).She placed the heatwrap on her naked skin in the waist region for 3-4 hours while watching television.The patient indicated the heatwrap was very hot.She checked the application area for itching and noticed swelling where the product had been applied and decided to remove it.The swelling and itching had resolved 24 hours later.The patient assessed her skin tone as medium (neither light nor dark).She stated she read the usage instructions for thermacare prior to device usage.The patient was not taking any medications during the time the problems/symptoms occurred.In addition, she indicated that she did not have any chronic disease.The patient denied having any abnormal skin conditions.She did not consult a healthcare professional for her problems/symptoms, but she applied cold press for the experienced events by herself.She confirmed that she did not have the box for the product because she used the product 3 or 4 years prior to this reporting.The color of the box she purchased was red.There was not any product remaining.Batch/lot number of product and expiration date were unknown.The reporting pharmacist confirmed that after having experienced these events, occurring 3-4 years ago, she discontinued use of thermacare lower back & hip.The reporting pharmacist thought the events experienced were related with thermacare lower back & hip.The outcome of the event "excessive heat/ thermacare lower back & hip was very hot" and "usage during the night/she read the usage instructions for thermacare prior to device usage" was unknown.The outcome of the other events was resolved on an unspecified date.According to the product quality complaint group for subclass of wrap/patch/pad too hot and adverse event safety request for investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8-hour product.The root cause category is non-assignable (complaint not confirmed as a quality defect).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.The 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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation as well as the subclass wrap/patch/pad too hot.Follow-up (29dec2016 and 30dec2016): new information received from a pharmacist (patient) includes: updated reporter from consumer to pharmacist, added suspect product indication, action taken with suspect product and reaction data (removed event blister, added new events heat allergy, itching in lumbar region, swelling in lumbar region).This follow-up is being submitted to notify that an investigation of the device is unable to be conducted.Follow-up attempts have been completed and no further information is expected.Follow up (24oct2019): new information received from pqc includes: investigation results.Follow-up (02apr2020) new information received from the product quality complaint group included investigational results for subclass adverse event safety request for investigation.Follow-up (05jun2020): this is a followup report to notify us food and drug administration (fda) that mfr report number 1066015-2017-00004 and mfr report number 1066015-2016-00161 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2016- 00161.Mfr report number 1066015-2017-00004 is to be considered as deleted.Follow-up attempts are completed.No further information is expected.
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