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| Device Problem
Leak/Splash (1354)
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| Patient Problems
Erythema (1840); Rash (2033)
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Event Type
malfunction
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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed).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 of adverse event for menstrual products.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.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity ranking is s3-skin-burn-per rpt-74091 bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp.
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Event Description
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Event verbatim [preferred term] red dots on his back [rash macular], pc: maybe some leakage/ there was some leakage from the product [device leakage].Case narrative:this is a spontaneous report from a contactable consumer (patient).A male patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number unknown) from an unspecified date at an unknown frequency for back problem and relieving pain in his back.The patient's medical history included burning in his nerves and back between appointments.Concomitant medications were not reported.The patient stated he received a notice about the thermacare patches from (wholesale name).He reported he had the thermacare product that wraps around, but he didn't have the product for the name, lot or expiration date.The patient reported he did have a back problem, which was why he used this product.The patient stated he had burning in his nerves and back between appointments.The patient reported he used this product to relieve pain in his back.The patient stated he had a reaction of red spots for one day.This happened over a month ago.When he removed the wrap there were red dots on his back.The patient stated his wife noticed red spots on his back.He reported maybe there was some leakage from the product because he never experienced this before.He had no other reaction other than the one day he had the patch on, and he had since used the other patches.The patient stated there were no reactions and the dots did go away.The patient stated 2 or 3 weeks ago while he was up at (place name) he bought a smaller patch of the product for his wife and she had no reaction.Action taken in response to the event for thermacare heatwrap was unknown.The outcome of the event was recovered.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non-assignable (complaint not confirmed).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 of adverse event for menstrual products.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.There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity ranking is s3-skin-burn-per rpt-74091 bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp.Additional information has been requested and will be provided as it becomes available.Follow-up (11apr2019): new information received from product quality complaints (pqc) group included: updated suspect product and provided product quality investigation results.This follow-up report is being submitted as a reportable device malfunction mdr.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported red spots on his back and suspected a device leakage from the product.No other adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.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 red spots on his back and suspected a device leakage from the product.No other adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.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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Event Description
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Event verbatim [preferred term] red dots on his back [rash macular], pc: maybe some leakage/ there was some leakage from the product [device leakage],.Case narrative:this is a spontaneous report from a contactable consumer (patient).A male patient of an unspecified age started to use thermacare heatwrap (thermacare lower back & hip) (device lot number unknown) from an unspecified date at an unknown frequency for back problem and relieving pain in his back.The patient's medical history included burning in his nerves and back between appointments.Concomitant medications were not reported.The patient stated he received a notice about the thermacare patches from (wholesale name).He reported he had the thermacare product that wraps around, but he didn't have the product for the name, lot or expiration date.The patient reported he did have a back problem, which was why he used this product.The patient stated he had burning in his nerves and back between appointments.The patient reported he used this product to relieve pain in his back.The patient stated he had a reaction of red spots for one day.This happened over a month ago.When he removed the wrap there were red dots on his back.The patient stated his wife noticed red spots on his back.He reported maybe there was some leakage from the product because he never experienced this before.He had no other reaction other than the one day he had the patch on, and he had since used the other patches.The patient stated there were no reactions and the dots did go away.The patient stated 2 or 3 weeks ago while he was up at (place name) he bought a smaller patch of the product for his wife and she had no reaction.Action taken in response to the event for thermacare heatwrap was unknown.Patient had discarded the product and didn't have it anymore, he no longer has the product, when finished with the product he threw them all away, and he doesn't have the product to send back.The marks on his back didn't concern him, he just figured it was from the heat.The outcome of the event was recovered.Additional information received from product quality complaint group included investigation results.The root cause category is non-assignable (complaint not confirmed as a quality defect).Since there was no batch # or return sample available for evaluation, there was limited device specific information provided to evaluate.A batch reference # and/or return sample is needed to complete a manufacturing and technical evaluation for the wrap involved in this case.There is not a product quality related trend identified for the subclass of cells damaged/leaking with lbh.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 reasonable suspicion of a device malfunction.The impact is cell leakage and the severity ranking is s3-skin-burn-per (b)(4) bridging pfizer hal severity # applied in the thermacare heatwrap rmp.Initial complaint assessment: site investigation #: (b)(4).The search returned a total of (b)(4) complaints for lbh during this time period.There were 7 complaints confirmed to have a manufacturing process root cause for cells damaged/leaking.The calculated complaints per million produced result of 642 was above the upper control limit of 14 per sop.The confirmed complaints could not be related to this event as a return sample nor batch # were available.There is no further action required.Based on this pcom search for the subclass of cells damaged for lbh the data did not show an increase over time ((b)(6) 2016 - (b)(6) 2019).There is a seasonality variation.There is not a trend identified for the subclass cells damaged/leaking.A trend for the subclass of cells damaged/leaking with lbh products was not identified.Also answered no for: further investigation required, process related, complaint confirmed, design related, capas in place, additional approval(s) required, and impact to quality, regulatory, stability and market / clinical.And prelim.And final confirmation status were not confirmed.No follow-up attempts are possible; information about batch number cannot be obtained.No further information is expected.Follow-up (11apr2019): new information received from product quality complaints (pqc) group included: updated suspect product and provided product quality investigation results.This follow-up report is being submitted as a reportable device malfunction mdr.Follow-up attempts are completed.No further information is expected.Follow-up (18apr2019): new information received from product quality complaints (pqc) group included: updated investigation summary with initial complaint assessment, sample was discarded, additional event verbatim "marks on his back" and if there are any impacts of this pqc.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported red spots on his back and suspected a device leakage from the product.No other adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.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 red spots on his back and suspected a device leakage from the product.No other adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.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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Manufacturer Narrative
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The root cause category is non-assignable (complaint not confirmed as a quality defect).Since there was no batch # or return sample available for evaluation, there was limited device specific information provided to evaluate.A batch reference # and/or return sample is needed to complete a manufacturing and technical evaluation for the wrap involved in this case.There is not a product quality related trend identified for the subclass of cells damaged/leaking with lbh.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 reasonable suspicion of a device malfunction.The impact is cell leakage and the severity ranking is s3-skin-burn-per (b)(4) bridging pfizer hal severity # applied in the thermacare heatwrap rmp.Initial complaint assessment: site investigation #: (b)(4).The search returned a total of (b)(4) complaints for lbh during this time period.There were 7 complaints confirmed to have a manufacturing process root cause for cells damaged/leaking.The calculated complaints per million produced result of 642 was above the upper control limit of 14 per sop.The confirmed complaints could not be related to this event as a return sample nor batch # were available.There is no further action required.Based on this pcom search for the subclass of cells damaged for lbh the data did not show an increase over time ((b)(6) 2016 - (b)(6) 2019).There is a seasonality variation.There is not a trend identified for the subclass cells damaged/leaking.A trend for the subclass of cells damaged/leaking with lbh products was not identified.Also answered no for: further investigation required, process related, complaint confirmed, design related, capas in place, additional approval(s) required, and impact to quality, regulatory, stability and market / clinical.And prelim.And final confirmation status were not confirmed.
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Search Alerts/Recalls
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