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| Lot Number S97473 |
| Device Problems
Use of Device Problem (1670); Temperature Problem (3022); Excessive Heating (4030)
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| Patient Problems
Bruise/Contusion (1754); Contusion (1787); Skin Discoloration (2074)
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| Event Date 05/01/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Process related: no.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Design related: no.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused discoloration on back while using the heatwrap.The cause of the alleged discoloration is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.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 dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28-nov-2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019 and.
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Event Description
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Event verbatim [preferred term] discoloration, bruising-type look on back/discoloration on her back and bruising on her back [skin discolouration] , discoloration, bruising-type look on back/discoloration on her back and bruising on her back [contusion] , put the thermacare wrap around her back around 8:30 before work and came home around 7-7:30, a little over 10 hours/pack was still hot and lasting long [device issue] , put the thermacare wrap around her back around 8:30 before work and came home around 7-7:30, a little over 10 hours [device use error] ,.Case narrative:this is a spontaneous report from a contactable consumer.This (b)(6)-year-old female consumer started to use thermacare heatwrap (thermacare lower back & hip) lot number s97473, expiration date mar2020, from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.Consumer was calling about the thermacare two pack back pain heating packs.Yesterday ((b)(6) 2019), consumer put the thermacare wrap around her back around 8:30 before work and came home around 7-7:30, a little over 10 hours.She received a call stating that there was a recall: something about the cells getting too hot.When she came in the door, she noticed that the heat pack was still really hot and lasting long.She looked at her back, and it had discoloration, not blistering, but a bruising-type look in the sections where she had the pack on.She was wondering what the adverse events were regarding the recall, specifically with what was going on her back in relation to the recall.She supposed the product could be used for other areas, but she used it for her lower back.Consumer had not had any treatment for the discoloration on her back or the bruising on her back.The action taken in response to the events with thermacare and outcome of the events were unknown.On (b)(6) 2019, the product quality complaint group provided following investigation findings: samples available: yes.Sample status: requested and not received.Process related: no.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Design related: no.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer alleges the heat wrap caused discoloration on back while using the heatwrap.The cause of the alleged discoloration is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.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 dhr, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures (37.6°c - 41.9°c) per spec-23451, effective date: 28-nov-2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.This incident was reviewed by aqrt on 11apr2019 and the outcome of aqrt is to recall the batches.The final scope include the following batches: s00639, s23902, s97473 and w37940.Document review summary: 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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c to 41.6°c) per spec 23451, effective: 28nov2016.The result was 39.4°c within range.There were no wrap attribute or variable defects recorded for the batch that would affect wrap temperature.On run day two laboratory investigation report (b)(4) was completed for one hot cell, an individual cell with the upper temperature of 44.7°c, above 44.0° celsius (per spec-23451, effective 28nov2016).The temperature limit for individual cells is 35.8°c to 44.0°c.Each wrap is composed of 16 cells.There were no other reports of hot cells within that wrap or within the batch.The investigation did not identify a laboratory related issue to explain the out of limits result.The lab tested 10 additional wraps and the results for individual cells passed with results of 37.1°c to 41.6°c within the limits.Event report er - 1842208 was completed by manufacturing to determine the root cause.The root cause for this event is classified under equipment, mechanical failure.Production operators found brine pump a14 dosing too low.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.The production operators adjusted the pump output and resumed production.Er - 1842208 determined there was no quality impact to the product or patients' safety.All site investigations were appropriately closed and addressed prior to batch release.Review of the shiftily production transition notes show the production operator made adjusts to the pump output and resumed production.The device history record for this lot has been reviewed from a manufacturing perspective.There are no known site investigations associated with this lot involving an adverse event safety request for investigation.Visual reserve sample evaluation description: the visual inspection of retain samples included 4 cartons, 8 pouches and the 8 wraps inside.Inspection shows no obvious defects to pouches or wraps.Inspection shows no obvious defects to cartons, pouches or wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 17may2019 for an unrelated complaint.Reserve sample testing result: no testing required.Confirmed reserve defect?:no.Lot-specific trend identified: no.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the third complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints evaluated were not confirmed to have a manufacturing related root cause for the complaint.Per sop-105746, a visual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to attachment trending graph adverse event s97473.On the basis of this evaluation, a trend does not exist for this lot.Severity of harm: s3.Additional information has been requested and will be provided as it becomes available.Follow-up (01jul2019): follow-up attempts are completed.No further information is expected.Follow-up (02may2019, 10oct2019, 16oct2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.New information received from a product quality complaint group includes: investigation findings and severity of harm.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the events skin discolouration, contusion, device issue, and device use error as described re considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events skin discolouration, contusion, device issue, and device use error as described re considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term]: put the thermacare wrap around her back around 8:30 before work and came home around 7-7:30, a little over 10 hours [device use error], discoloration, bruising-type look on back/discoloration on her back and bruising on her back [skin discolouration], discoloration, bruising-type look on back/discoloration on her back and bruising on her back [contusion], put the thermacare wrap around her back around 8:30 before work and came home around 7-7:30, a little over 10 hours/pack was still hot and loasting long [device issue], narrative: this is a spontaneous report from a contactable consumer.This 56-year-old female consumer started to use thermacare heatwrap (thermacare lower back & hip) lot number s97473, expiration date mar2020, from an unspecified date at an unknown frequency for an unspecified indication.The patient medical history and concomitant medications were not reported.Consumer was calling about the thermacare two pack back pain heating packs.Yesterday (01may2019), consumer put the thermacare wrap around her back around 8:30 before work and came home around 7-7:30, a little over 10 hours.She received a call stating that there was a recall: something about the cells getting too hot.When she came in the door, she noticed that the heat pack was still really hot and lasting long.She looked at her back, and it had discoloration, not blistering, but a bruising-type look in the sections where she had the pack on.She was wondering what the adverse events were regarding the recall, specifically with what was going on her back in relation to the recall.She supposed the product could be used for other areas, but she used it for her lower back.Consumer had not had any treatment for the discoloration on her back or the bruising on her back.The action taken in response to the events with thermacare and outcome of the events were unknown.Sample was available.According to the product quality complaint group provided following investigation findings: severity of harm: s3.Summary of investigation: batch s97473 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer stated the wrap caused "discoloration." the cause of the consumer stating the wrap caused "discoloration" is inconclusive since review of records does not provide evidence to support a defective product.A return sample is not available to confirm if a device defect occurred.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.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 dhr,release testing data or, inspection of retained samples.Retained samples met the product description.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures(37.6°c - 41.9°c) per spec-23451, effective date: (b)(6) 2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.According to rpt-38832, hazard analysis: thermacare heat wrap products: 8 and 12hr, section 10.1-market actions (recall), effective date: (b)(6) 2020, in (b)(6) 2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower, back and hip, include s97473 (us), s00639 (germany/switzerland), s23902(uk/ireland), and w37940 (germany/switzerland).The recall action was taken after the batches were released with an out of specification result for high temperature cell(s) and no product isolation of impacted product was performed.Release of these batches without product isolation is a compliance gap.The manufacturing investigation (pr 3938189, closed 04-sep-2019) resulted in corrective actions including improving procedures for containing and investigating nonconforming product.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is thethird complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the subclass.Per sop-105746, complaint trending guideline, effective (b)(6) 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.The calculated complaints produced per million (cpmp) result of 20 was below the upper control limit (ucl) of 33.9.On the basis of this evaluation, a trend does not exist for this batch.On the basis of this evaluation, a trend does not exist for this batch.A return sample has not been received at the site for evaluation as of (b)(6) 2020.Follow-up (01jul2019): follow-up attempts are completed.No further information is expected.Follow-up (02may2019, 10oct2019, 16oct2019): this follow-up report is being submitted to upgrade this case to a reportable mdr.New information received from a product quality complaint group includes: investigation findings and severity of harm.Follow-up attempts are completed.No further information is expected.Follow-up(20dec2019): follow-up attempts are completed.No further information is expected.Follow-up (02jun2020): new information received from product quality complaint group includes updated investigation results.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Summary of investigation: batch s97473 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserved samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer stated the wrap caused "discoloration." the cause of the consumer stating the wrap caused "discoloration" is inconclusive since review of records does not provide evidence to support a defective product.A return sample is not available to confirm if a device defect occurred.The product effect may vary with each individual.The product quality for the batch is not impacted by this complaint.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 dhr,release testing data or, inspection of retained samples.Retained samples met the product description.After a review of the lot thermal records, all wraps met the required wrap batch average temperatures(37.6°c - 41.9°c) per spec-23451, effective date: (b)(6) 2016.Investigations for the lot (lir-1842197 and er-1842208) involving wrap cell temperatures were for hot cells.A low brine dose can cause a hotter than normal temperature profile due to lack of brine allowing more oxygen into the cell, creating a hotter reaction between the chemistry and brine.An investigation, (b)(4), was opened after an fda inspection to address not performing isolation.The main root cause of this event is related to misunderstanding the cap procedure for investigating, retesting and isolating product with a high temperature cell.This is defined as root cause method/procedure-document unclear/lacking detail.In addition, human error is a contributing factor: is not a practice to train on changes to forms as forms are not part of the training curriculum.According to rpt-38832, hazard analysis: thermacare heat wrap products: 8 and 12hr, section 10.1-market actions (recall), effective date: (b)(6) 2020, in (b)(6) 2019, pfizer initiated a recall of 4 batches of thermacare heat/wraps.The batches, all lower, back and hip, include s97473 (us), s00639 (germany/switzerland), s23902(uk/ireland), and w37940 (germany/switzerland).The recall action was taken after the batches were released with an out of specification result for high temperature cell(s) and no product isolation of impacted product was performed.Release of these batches without product isolation is a compliance gap.The manufacturing investigation ((b)(6), closed (b)(6) 2019) resulted in corrective actions including improving procedures for containing and investigating nonconforming product.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is thethird complaint for the sub class adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The previous complaints were not confirmed to have a manufacturing related root cause for the subclass.Per sop-105746, complaint trending guideline, effective (b)(6) 2020, the complaint was evaluated to identify a potential trend for the lot and subclass.The calculated complaints produced per million (cpmp) result of 20 was below the upper control limit (ucl) of 33.9.On the basis of this evaluation, a trend does not exist for this batch.On the basis of this evaluation, a trend does not exist for this batch.A return sample has not been received at the site for evaluation as of (b)(6) 2020.
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Search Alerts/Recalls
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