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There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn per hazard analysis thermacare heat wrap product: 8 and 12 hours.Complaint class: product appearance.Complaint subclass: cells damaged/leaking.Sterile product: no.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8hr 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.There is not a product quality related trend identified for the subclass cells damaged/leaking.There was no regulatory impact, no product quality impact, no market /clinical impact, and no stability impact.It was not process related, and final confirmation status was not confirmed.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 cells damaged/leaking.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.Batch/ process record review: document review summary: there is no device history report (dhr) reviewed for an unknown batch number.Reserve sample evaluation and testing not required.No lot-specific trend identified as lot trend was not performed as the lot number is unknown.No expedite trend identified: an evaluation was made by searching for possible trends for this subclass.
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Event verbatim [preferred term] each packet was leaking [device leakage], i use them on my back when i run out of the lower back ones [intentional device use issue].Case narrative: this is a spontaneous report from a contactable consumer.This female patient started to use thermacare heatwraps (thermacare neck/wrist/shoulder).The patient medical history and concomitant medications were not reported.The consumer stated that she opened a brand new box of these and all 4 packages inside the box were sealed, when she opened them each packet was leaking so she couldn't use any of them, she was very disappointed as these tend to be very helpful for her back and shoulder.The patient used them on her back when she run out of the lower back ones.The action taken with thermacare heatwraps and outcome of the event were unknown.Product quality complaint group provided investigation findings as follows: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn per hazard analysis thermacare heat wrap product: 8 and 12 hours.Complaint class: product appearance.Complaint subclass: cells damaged/leaking.Sterile product: no.Summary of investigation: this investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8hr 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.There is not a product quality related trend identified for the subclass cells damaged/leaking.There was no regulatory impact, no product quality impact, no market /clinical impact, and no stability impact.It was not process related, and final confirmation status was not confirmed.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 cells damaged/leaking.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.Batch/ process record review: document review summary: there is no device history report (dhr) reviewed for an unknown batch number.Reserve sample evaluation and testing not required.No lot-specific trend identified as lot trend was not performed as the lot number is unknown.No expedite trend identified: an evaluation was made by searching for possible trends for this subclass.The following complaint intake, triage and investigation (citi) search was performed: scope: date of contact: 29nov2016 through 29nov2019/manufacturing site: (site name).Complaint class: product /appearance /complaint sub class: heat cells damaged/leaking and cells damaged/leaking.The citi customizable search returned a total of 16 complaint for neck/shoulder/wrist (nsw) 8hr products during this time period for the class/subclass.There were one complaints confirmed as having a manufacturing related root cause of the wrap having heat cells/damaged/ leaking and cells damaged/leaking.Pr for batch - j68754: the root cause of the wraps not being dosed with brine solution was equipment: the logic was not programmed to detect if the proximity switch at the brine dosing arm is detecting the motion of the arm when the production line is running.This allowed the production line continue to run without incurring a fault even though the brine pumps were not being driven.Therefore, no brine was being injected into the cells producing products with lower weights that was detected at the check weigher and diverted from the packaging line.Commitment pr# # was completed to modify the logic to detect if the brine dosing arm proximity switch is not operational when the line is running.This commitment was completed on 24mar2015, after the manufacture of the wraps in this event.: no corrective actions and preventive actions.Based on this citi search, there is not a trend identified for the subclass heat cells damaged/leaking and cells damaged/leaking for nsw 8hr products, refer to attached trending chart heat cells damaged leaking 29nov2016 to 29nov2019.No further action is required.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass heat cells damaged/leaking and cells damaged/leaking for nsw 8hr products, refer to attached trending chart heat cells damaged leaking 29nov2016 to 29nov2019.No further action is required.Site sample status: not received.Also provided for complaint class: external cause investigation.Complaint sub-class: adverse event/serious/unknown.No capa previously identified, and no full investigation required.Qa review & rationale and summary of investigation: see below, same as conclusion.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient experienced a leakage while using the product.There was no reported burn or serious injury.Company clinical evaluation comment: based on the available information, the patient reported that each packet was leaking (device leakage) which is non-serious.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The other event intentional device use issue is non-serious.The company is conducting a further review on this investigation, and additional follow-up will be reported when the evaluation is completed.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the available information, the patient reported that each packet was leaking (device leakage) which is non-serious.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The other event intentional device use issue is non-serious.The company is conducting a further review on this investigation, and additional follow-up will be reported when the evaluation is completed.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.Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.
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