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| Lot Number S23831 |
| Device Problems
Leak/Splash (1354); Moisture Damage (1405)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation results: batch s23831 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the four pouched wraps inside and shows no obvious defects to carton or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2017.An evaluation of the complaint history confirms that this is the first complaint for the sub class wet/damp received at the albany site requiring an evaluation for this batch.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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per lower back and hip, spec-23451, effective: 28-nov-2016.A total of 1704 pti (pouch leak) tests were performed with 3 failures.Pouch leak maximum acceptance limit for a sample size of 1670 pti tests is 28 failures per spec-23451, effective: 28-nov-2016.There were no pack attribute defects recorded for the batch.Review of the shiftly transition notes show no unusual occurrences in the flow wrapper during manufacturing of the batch.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).In general - as wraps heat-up and.
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Event Description
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Event verbatim [preferred term] one patch of thermacare lower back/hip heatwrap moistened on [device leakage] ,.Case narrative: this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s2383 , expiration date 30apr2019, via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The pharmacist reported one patch of thermacare lower back/hip heatwrap moistened on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was not reported.Quality assurance results received on 01dec2017 for thermacare heatwrap include investigation results: batch s23831 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the four pouched wraps inside and shows no obvious defects to carton or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6)2017.An evaluation of the complaint history confirms that this is the first complaint for the sub class wet/damp received at the (b)(4) site requiring an evaluation for this batch.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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per lower back and hip, spec-23451, effective: 28-nov-2016.A total of 1704 pti (pouch leak) tests were performed with 3 failures.Pouch leak maximum acceptance limit for a sample size of 1670 pti tests is 28 failures per spec-23451, effective: 28-nov-2016.There were no pack attribute defects recorded for the batch.Review of the shiftly transition notes show no unusual occurrences in the flow wrapper during manufacturing of the batch.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).In general, as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A small pouch leak can cause the wrap to prematurely heat up inside the pouch, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.However; once the wrap is open there is no way to determine if a pouch leak was present.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 the batch device history record, in process attributes and variable quality checks 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.Severity of harm: no source value.Company clinical evaluation comment the event "one patch of thermacare lower back/hip heatwrap moistened " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "one patch of thermacare lower back/hip heatwrap moistened " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.
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Manufacturer Narrative
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Investigation results: batch s23831 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the four pouched wraps inside and shows no obvious defects to carton or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2017.An evaluation of the complaint history confirms that this is the first complaint for the sub class wet/damp received at the albany site requiring an evaluation for this batch.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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per lower back and hip, spec-23451, effective: 28-nov-2016.A total of 1704 pti (pouch leak) tests were performed with 3 failures.Pouch leak maximum acceptance limit for a sample size of 1670 pti tests is 28 failures per spec-23451, effective: 28-nov-2016.There were no pack attribute defects recorded for the batch.Review of the shiftly transition notes show no unusual occurrences in the flow wrapper during manufacturing of the batch.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).In general - as wraps heat-up and.
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Event Description
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Event verbatim [preferred term] one patch of thermacare lower back/hip heatwrap moistened on [device leakage], case narrative:this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s2383 , expiration date 30apr2019, via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The pharmacist reported one patch of thermacare lower back/hip heatwrap moistened on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was not reported.Quality assurance results received on (b)(6) 2017 for thermacare heatwrap include investigation results: batch s23831 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the four pouched wraps inside and shows no obvious defects to carton or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2017.An evaluation of the complaint history confirms that this is the first complaint for the sub class wet/damp received at the (manufacturing site) requiring an evaluation for this batch.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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per lower back and hip, spec-23451, effective: (b)(6) 2016.A total of 1704 pti (pouch leak) tests were performed with 3 failures.Pouch leak maximum acceptance limit for a sample size of 1670 pti tests is 28 failures per spec-23451, effective: (b)(6) 2016.There were no pack attribute defects recorded for the batch.Review of the shiftly transition notes show no unusual occurrences in the flow wrapper during manufacturing of the batch.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).In general, as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A small pouch leak can cause the wrap to prematurely heat up inside the pouch, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.However; once the wrap is open there is no way to determine if a pouch leak was present.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 the batch device history record, in process attributes and variable quality checks 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.Severity of harm: no source value.Amendment: this follow-up report is being submitted to amend previously reported information: operator of device populated as lay user/patient.Follow-up (24dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Company clinical evaluation comment the event "one patch of thermacare lower back/hip heatwrap moistened " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "one patch of thermacare lower back/hip heatwrap moistened " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] one patch of thermacare lower back/hip heatwrap moistened on [device leakage].Case narrative:this is a spontaneous report from a contactable pharmacist.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare lower back & hip), device lot number s2383 , expiration date 30apr2019, via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication.The patient medical history and concomitant medications were not reported.The pharmacist reported one patch of thermacare lower back/hip heatwrap moistened on an unspecified date.The action taken with thermacare heatwrap and the outcome of the event was not reported.Quality assurance results received on 01dec2017 for thermacare heatwrap include investigation results: batch s23831 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the four pouched wraps inside and shows no obvious defects to carton or pouched wraps.Form-(b)(4) retain sample inspection form documented the retain evaluation performed on 30-nov-2017.An evaluation of the complaint history confirms that this is the first complaint for the sub class wet/damp received at the (manufacturing site) requiring an evaluation for this batch.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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per lower back and hip, spec-23451, effective: 28-nov-2016.A total of 1704 pti (pouch leak) tests were performed with 3 failures.Pouch leak maximum acceptance limit for a sample size of 1670 pti tests is 28 failures per spec-23451, effective: 28-nov-2016.There were no pack attribute defects recorded for the batch.Review of the shiftly transition notes show no unusual occurrences in the flow wrapper during manufacturing of the batch.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).In general, as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A small pouch leak can cause the wrap to prematurely heat up inside the pouch, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.However; once the wrap is open there is no way to determine if a pouch leak was present.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 the batch device history record, in process attributes and variable quality checks 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.Severity of harm: no source value.Company clinical evaluation comment: the event "one patch of thermacare lower back/hip heatwrap moistened " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.Amendment: this follow-up report is being submitted to amend previously reported information: operator of device populated as lay user/patient., comment: the event "one patch of thermacare lower back/hip heatwrap moistened " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.
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Manufacturer Narrative
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Investigation results: batch s23831 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the four pouched wraps inside and shows no obvious defects to carton or pouched wraps.Form-(b)(4) retain sample inspection form documented the retain evaluation performed on 30-nov-2017.An evaluation of the complaint history confirms that this is the first complaint for the sub class wet/damp received at the albany site requiring an evaluation for this batch.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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per lower back and hip, spec-23451, effective: 28-nov-2016.A total of 1704 pti (pouch leak) tests were performed with 3 failures.Pouch leak maximum acceptance limit for a sample size of 1670 pti tests is 28 failures per spec-23451, effective: 28-nov-2016.There were no pack attribute defects recorded for the batch.Review of the shiftly transition notes show no unusual occurrences in the flow wrapper during manufacturing of the batch.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).In general - as wraps heat-up and.
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Event Description
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Event verbatim [preferred term] one patch of thermacare lower back/hip heatwrap moistened on [device leakage].Case narrative:this is a spontaneous report from a contactable pharmacist regarding thermacare heatwrap (thermacare lower back & hip) device lot number s23831, expiration date 30apr2019.The pharmacist reported one patch of thermacare lower back/hip heatwrap moistened.Action taken and outcome was not reported.Quality assurance results received on 01dec2017 for thermacare heatwrap include investigation results: batch s23831 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the four pouched wraps inside and shows no obvious defects to carton or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 30-nov-2017.An evaluation of the complaint history confirms that this is the first complaint for the sub class wet/damp received at the (manufacturing site) requiring an evaluation for this batch.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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per lower back and hip, spec-23451, effective: 28-nov-2016.A total of 1704 pti (pouch leak) tests were performed with 3 failures.Pouch leak maximum acceptance limit for a sample size of 1670 pti tests is 28 failures per spec-23451, effective: 28-nov-2016.There were no pack attribute defects recorded for the batch.Review of the shifty transition notes show no unusual occurrences in the flow wrapper during manufacturing of the batch.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).In general, as wraps heat-up and cool, condensation (moisture/water droplets) are generated.A small pouch leak can cause the wrap to prematurely heat up inside the pouch, which subsequently cools, and produces condensation inside the pouch which was noted by the consumer.However; once the wrap is open there is no way to determine if a pouch leak was present.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 the batch device history record, in process attributes and variable quality checks 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.Severity of harm: no source value.Amendment: this follow-up report is being submitted to amend previously reported information: operator of device populated as lay user/patient.Follow-up (24dec2019): this follow-up is being submitted to notify that an investigation of the device is ongoing.Follow-up (19feb2020): this follow-up report is being submitted to upgrade this case to a final reportable mdr.This follow-up report is being submitted to amend previously reported information: operator of device updated to "health professional"., comment: the event "one patch of thermacare lower back/hip heatwrap moistened " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Investigation results: batch s23831 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the four pouched wraps inside and shows no obvious defects to carton or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 30-nov-2017.An evaluation of the complaint history confirms that this is the first complaint for the sub class wet/damp received at the albany site requiring an evaluation for this batch.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.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c-41.6°c) per lower back and hip, spec-23451, effective: 28-nov-2016.A total of 1704 pti (pouch leak) tests were performed with 3 failures.Pouch leak maximum acceptance limit for a sample size of 1670 pti tests is 28 failures per spec-23451, effective: 28-nov-2016.There were no pack attribute defects recorded for the batch.Review of the shiftly transition notes show no unusual occurrences in the flow wrapper during manufacturing of the batch.This batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).
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Search Alerts/Recalls
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