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An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake triage and investigation (citi) search was performed: date contacted: (b)(6) 2016 through (b)(6) 2019.Manufacturing site: (b)(4).Complaint class: external cause investigation.Complaint sub class: adverse event safety request for investigation.The complaint intake triage and investigation (citi) search returned a total of 521 complaints for lower back and hip (lbh) products during this time 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 adverse events complaint subclass show an increase in (b)(6) 2018 thru (b)(6) 2019.This is a seasonality change in combination with a change in safety's procedure wsr-cp001-wi 110, "case processing principles product quality complaint guidance", updated on august 20, 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may 2019.Complaints increased due 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 apr2019.Seven complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The remaining recall batches were not reported.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may 2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8.
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Developed blisters after using product [blister], this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip), 6 count box, wrap size l/xl, lot number and expiration date was not provided, from an unspecified date to an unspecified date for pain, back spasms.The patient medical history and concomitant medications were not reported.Caller received a notice regarding recall and was told to call for reimbursement.Consumer purchased a six pack of thermacare wraps '3 years ago, in (b)(6) 2017.She used one of the wraps from the 6-count box and developed blisters after using product on an unspecified date.Consumer had the wrap on and fell asleep for a short nap.She did not sleep with the wrap overnight.The action taken in response to the event was unknown.The clinical outcome of the event was unknown.Consumer has discarded the used wrap but retained the other 5 wraps.A sample of the product is not available for return.Additional information received from product quality complaint (pqc) group included investigation results.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake triage and investigation (citi) search was performed: date contacted: (b)(6) 2016 through (b)(6) 2019.Manufacturing site: pfizer (b)(4).Complaint class: external cause investigation.Complaint sub class: adverse event safety request for investigation.The complaint intake triage and investigation (citi) search returned a total of 521 complaints for lower back and hip (lbh) products during this time 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 adverse events complaint subclass show an increase in october 2018 thru march 2019.This is a seasonality change in combination with a change in safety's procedure wsr-cp001-wi 110, "case processing principles product quality complaint guidance", updated on august 20, 2018 that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may 2019.Complaints increased due 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 apr2019.Seven complaints were related to batch s97473.None were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.The remaining recall batches were not reported.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may 2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.This is also observed in a review of the 24 month trend chart for this subclass.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo (b)(4) and are not valid adverse events.Based on this complaint intake triage and investigation (citi) search, there is not a trend identified for the subclass of adverse event safety request for investigation for lbh products, this investigation was conducted for an unknown lot number of lbh.Conclusion: 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.There is not a product quality related trend identified for the subclass adverse event safety request for investigation.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.The severity is s3-skin burn, skin blister per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hour, effective 23apr2019, version 5.0.The plant has reviewed this batch from a manufacturing perspective.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.Additional information has been requested and will be provided as it becomes available.Follow-up (05jul2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (12aug2019): follow-up attempts are completed.No further information is expected.Follow-up (17may2019 and 18aug2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.Additional information received from product quality complaint group includes investigation results.Company clinical evaluation comment: based on the information provided, the event blister as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Comment: based on the information provided, the event blister as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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