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| Lot Number AA2375 |
| Device Problems
Loss of or Failure to Bond (1068); Insufficient Heating (1287)
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| Patient Problems
Contusion (1787); Fall (1848); Pain (1994); Discomfort (2330)
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| Event Date 10/01/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch eats at time of release.The severity of pouch leaks is s1 no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat sea technology.This document will be attached to the complaint record in the global database and closed with no further action taken.Summary for drug safety unit (dsu): the root cause for never worked, too cool, did not as long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not sea complete y (open pouch) an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer ached.Product produced after the implementation date will be investigated.
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Event Description
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It didn't heat up as warm as they normally do and it just didn't have the effect [device ineffective], it didn't heat up as warm as they normally do and it just didn't have the effect.[device issue], fell down a flight of stairs causing contusions from head to toe [fall], fell down a flight of stairs causing contusions from head to toe [contusion], neck, shoulders, back and hips in bad condition [musculoskeletal discomfort].Case narrative: this is a spontaneous report from a contactable consumer.This female (b)(6) female consumer reported that she started to use thermacare heatwrap (thermacare muscle & joint) (device lot number aa2375, expiration date nov2021, upc# (b)(4),) from an unspecified date for upper, mid and lower back pain.Relevant medical history included she was in a bad car accident she was at the hospital last week ((b)(6)2019) because of it so she had a lot of back problems.Relevant concomitant medications included unspecified pain medicine and a muscle relaxer since (b)(6) 2019.The consumer reported in (b)(6) 2019, the wrap didn't stick on her back very well on unknown date.She also said it didn't get as hot as it usually does and she uses them just about every day.It only heats for a little bit for about hour and hour and half: it didn't heat up as warm as they normally do and it just didn't have the effect.The patient was hospitalized.On an unspecified date, the patient fell down a flight of stairs causing contusions from head to toe and was currently being treated by orthopedic, physical therapy, chiropractor, and receiving si injections.She states her neck, shoulders, back and hips are in bad condition.The action taken with the thermacare therapy was permanently withdrawn.The patient was using another brand.The outcome of the events was not provided.Per the product quality group: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch eats at time of release.The severity of pouch leaks is s1 no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat sea technology.This document will be attached to the complaint record in the global database and closed with no further action taken.Summary was that the root cause for never worked, too cool, did not as long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not sea complete y (open pouch) an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer ached.Product produced after the implementation date will be investigated.Severity rating and malfunction assessment from dchu includes that severity of harm was s1.A summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Root cause category was non-assignable (complaint not confirmed).Site sample status was not received.Follow-up (02dec2019): new information received from product quality complaint group includes investigation results.Follow-up (06dec2019): new information received from product quality complaint includes: severity rating and malfunction assessment from dchu.Follow-up (19dec2019): new information received from a contactable consumer includes event data (events added fell down a flight of stairs causing contusions from head to toe).Company clinical evaluation comment: based on the available information, the patient reported the events "it didn't heat up as warm as they normally do and it just didn't have the effect" (device ineffective and device issue) requiring hospital admission are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events "fell down a flight of stairs causing contusions from head to toe" (fall and contusions) and "neck, shoulders, back and hips in bad condition" (musculoskeletal discomfort) are considered serious bodily injury 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 available information, the patient reported the events "it didn't heat up as warm as they normally do and it just didn't have the effect" (device ineffective and device issue) requiring hospital admission are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events "fell down a flight of stairs causing contusions from head to toe" (fall and contusions) and "neck, shoulders, back and hips in bad condition" (musculoskeletal discomfort) are considered serious bodily injury 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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It didn't heat up as warm as they normally do and it just didn't have the effect [device ineffective].It didn't heat up as warm as they normally do and it just didn't have the effect.[device issue].Case description: this is a spontaneous report from a contactable consumer reporting for herself.This female 48-year-old female consumer reported that she started to use thermacare heatwrap (thermacare muscle & joint) (device lot number: aa2375, expiration date: nov2021, upc#: 305733013014) from an unspecified date for upper, mid and lower back pain.Relevant medical history included she was in a bad car accident she was at the hospital last week (on (b)(6) 2019) because of it so she had a lot of back problems, fell down a flight of stairs causing contusions from head to toe (currently being treated by orthopedic, physical therapy, chiropractor, and receiving si injections) and neck, shoulders, back and hips are in bad condition.Relevant concomitant medications included unspecified pain medicine and a muscle relaxer since on (b)(6) 2019.The consumer reported, the wrap didn't stick on her back very well on unknown date.She also said it didn't get as hot as it usually does and she uses them just about every day on (b)(6) 2019.It only heats for a little bit for about hour and hour and half: it didn't heat up as warm as they normally do and it just didn't have the effect.The patient was hospitalized and received treatment.The action taken with the thermacare therapy was permanently withdrawn.The patient was using another brand.The outcomes of 'didn't heat up as warm as they normally do,' and 'it just didn't have the effect' were not resolved.Per the product quality group: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch eats at time of release.The severity of pouch leaks is s1 no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat sea technology.This document will be attached to the complaint record in the global database and closed with no further action taken.Summary was that the root cause for never worked, too cool, did not as long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not sea complete y (open pouch) an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically u trasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer ached.Product produced after the implementation date will be investigated.Severity rating and malfunction assessment from dchu includes that severity of harm was s1.A summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Root cause category was non-assignable (complaint not confirmed).Site sample status was not received.Additional information has been requested and will be provided as it becomes available.Follow-up (02dec2019): new information received from product quality complaint group includes investigation results.Follow-up (06dec2019): new information received from product quality complaint includes: severity rating and malfunction assessment from dchu.Follow-up (19dec2019): new information received from a contactable consumer includes event data (events added fell down a flight of stairs causing contusions from head to toe).Amendment: this follow-up is being submitted to amend previously reported information: outcome of event updated in narrative.Follow-up (07jan2020): this is a follow-up spontaneous report received from a product quality complaint group included: the events "fell down a flight of stairs causing contusions from head to toe and neck, shoulders, back and hips are in bad condition" were changed to medical history, case downgraded to non-reportable.
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Manufacturer Narrative
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Complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch eats at time of release.The severity of pouch leaks is s1 no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in place to replace the ultrasonic sealers with heat sea technology.This document will be attached to the complaint record in the global database and closed with no further action taken.Summary for drug safety unit (dsu): the root cause for never worked, too cool, did not as long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not sea complete y (open pouch) an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically utrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer ached.Product produced after the implementation date will be investigated.
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Manufacturer Narrative
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Complaints received at the site in the global complaint database, related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure, they are due to "open pouch", and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch eats at time of release.The severity of pouch leaks is s1 no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat sea technology.This document will be attached to the complaint record in the global database.And closed with no further action taken.Summary for drug safety unit (dsu): the root cause for never worked, too cool, did not as long enough and squeeze tube complaint sub classless, is due to a pouch (primary packaging) that did not seal completely, open pouch: an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment, specifically u trasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1.No harm to customer ached.Product produced after the implementation date will be investigated.
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Event Description
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Event verbatim [preferred term] it didn't heat up as warm as they normally do and it just didn't have the effect [device ineffective] , it didn't heat up as warm as they normally do and it just didn't have the effect.[device issue] , fell down a flight of stairs causing contusions from head to toe [fall] , neck, shoulders, back and hips in bad condition [musculoskeletal discomfort] ,.Case narrative:this is a spontaneous report from a contactable consumer.This female 48-year-old female consumer reported that she started to use thermacare heatwrap (thermacare muscle & joint) (device lot number aa2375, expiration date nov2021, upc# 305733013014,) from an unspecified date for upper, mid and lower back pain.Relevant medical history included she was in a bad car accident she was at the hospital last week ((b)(6) 2019) because of it so she had a lot of back problems.Relevant concomitant medications included unspecified pain medicine and a muscle relaxer since (b)(6) 2019.The consumer reported in (b)(6) 2019, the wrap didn't stick on her back very well on unknown date.She also said it didn't get as hot as it usually does and she uses them just about every day.It only heats for a little bit for about hour and hour and half: it didn't heat up as warm as they normally do and it just didn't have the effect.The patient was hospitalized.On an unspecified date, the patient fell down a flight of stairs causing contusions from head to toe and was currently being treated by orthopedic, physical therapy, chiropractor, and receiving si injections.She states her neck, shoulders, back and hips are in bad condition.The action taken with the thermacare therapy was permanently withdrawn.The patient was using another brand.The outcomes of 'didn't heat up as warm as they normally do,' and 'it just didn't have the effect' were not resolved and for the remaining events was not provided.Per the product quality group: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in the global complaint database.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch eats at time of release.The severity of pouch leaks is s1 no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat sea technology.This document will be attached to the complaint record in the global database and closed with no further action taken.Summary was that the root cause for never worked, too cool, did not as long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not sea complete y (open pouch) an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically u trasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer ached.Product produced after the implementation date will be investigated.Severity rating and malfunction assessment from dchu includes that severity of harm was s1.A summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Root cause category was non-assignable (complaint not confirmed).Site sample status was not received.Additional information has been requested and will be provided as it becomes available.Follow-up (02dec2019): new information received from product quality complaint group includes investigation results.Follow-up (06dec2019): new information received from product quality complaint includes: severity rating and malfunction assessment from dchu.Follow-up (19dec2019): new information received from a contactable consumer includes event data (events added fell down a flight of stairs causing contusions from head to toe) amendment: this follow-up is being submitted to amend previously reported information: outcome of event updated in narrative.Company clinical evaluation comment: based on the available information, the patient reported the events "it didn't heat up as warm as they normally do and it just didn't have the effect" (device ineffective and device issue) requiring hospital admission are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events "fell down a flight of stairs causing contusions from head to toe" (fall and contusions) and "neck, shoulders, back and hips in bad condition" (musculoskeletal discomfort) are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event contusions is not considered associated with the use of the device per narrative, it was caused by the fall.The other events are medically assessed as associated with the use of the device., comment: based on the available information, the patient reported the events "it didn't heat up as warm as they normally do and it just didn't have the effect" (device ineffective and device issue) requiring hospital admission are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events "fell down a flight of stairs causing contusions from head to toe" (fall and contusions) and "neck, shoulders, back and hips in bad condition" (musculoskeletal discomfort) are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event contusions is not considered associated with the use of the device per narrative, it was caused by the fall.The other 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] it didn't heat up as warm as they normally do and it just didn't have the effect [device ineffective], it didn't heat up as warm as they normally do and it just didn't have the effect.[device issue].Narrative: this is a spontaneous report from a contactable consumer reporting for herself.This 48-year-old female consumer reported that she started to use thermacare heatwrap (thermacare muscle & joint) (device lot number aa2375, expiration date nov2021, upc# 305733013014,) from an unspecified date for upper, mid and lower back pain.Relevant medical history included she was in a bad car accident she was at the hospital last week ((b)(6) 2019) because of it so she had a lot of back problems, fell down a flight of stairs causing contusions from head to toe (currently being treated by orthopedic, physical therapy, chiropractor, and receiving si injections) and neck, shoulders, back and hips are in bad condition.Relevant concomitant medications included unspecified pain medicine and a muscle relaxer since (b)(6) 2019.The consumer reported, the wrap didn't stick on her back very well on unknown date.She also said it didn't get as hot as it usually does and she uses them just about every day in (b)(6) 2019.It only heats for a little bit for about hour and hour and half: it didn't heat up as warm as they normally do and it just didn't have the effect.The patient was hospitalized and received treatment.The action taken with the thermacare therapy was permanently withdrawn.The patient was using another brand.The outcomes of 'didn't heat up as warm as they normally do,' and 'it just didn't have the effect' were not resolved.Per new results from the product quality group: 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.There were no wrap attribute or variable defects recorded for the batch.The material records for nsw/mj skin contact adhesive laminate (sca); material number # were reviewed.There were three batches of sca used in the manufacturing of the batch, batch 2001027407, 2001045652 and 2001045653.There were no raw material incident forms completed for the batch of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch reviewed from a manufacturing perspective.There were no investigations associated with this batch for wraps' adhesion.The visual inspection of a retain sample included one carton and one pouched wraps inside.Sample shows no obvious defects.An evaluation of the complaint history confirms that this is the second complaint for the sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause related to the subclass.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 20.This result was below the upper control limit (ucl) of 189.5 complaints per sop# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.The root cause category is non assignable (complaint not confirmed as a quality defect).A wrap was not returned in the returned consumer sample; therefore, the complaint cannot be confirmed.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.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.Return sample evaluation: wrap not returned.Additional information received from product quality complaint group on (b)(6) 2020.Severity of harm was s1 for subclass adhesion/fastening defect.Summary of investigation: batch aa2375 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve 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).The evaluation of the consumer returned sample did not provide any additional evidence to determine a root cause of the wrap not adhering to consumer during use; there were no defects found on the wraps.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause related to the subclass.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 20.This result was below the upper control limit (ucl) of 189.5 complaints per (b)(4) complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.The sample was received at the site.Return sample evaluation: pouch is opened by consumer.No obvious defects.Follow-up (02dec2019): new information received from product quality complaint group includes investigation results.Follow-up (06dec2019): new information received from product quality complaint includes: severity rating and malfunction assessment from dchu.Follow-up (19dec2019): new information received from a contactable consumer includes event data (events added fell down a flight of stairs causing contusions from head to toe).Amendment: this follow-up is being submitted to amend previously reported information: outcome of event updated in narrative.Follow-up (07jan2020): this is a follow-up spontaneous report received from a product quality complaint group included: the events "fell down a flight of stairs causing contusions from head to toe and neck, shoulders, back and hips are in bad condition" were changed to medical history, case downgraded to non-reportable.Follow-up (02mar2020): follow-up attempts are completed.No further information is expected.Follow-up (14may2020): new information received from product quality complaint includes: investigation summary.Amendment: this follow-up report is being submitted to amend previously reported information: unchecked adverse event checkbox as only product complaint was reported.Follow-up (08jun2020 and 08jun2020): this is a follow-up spontaneous mail trail received in response to query to confirm that a return sample has been received at the site.New information received on 08jun2020 from product quality complaint includes updated investigation result.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number 1066015-2019-00565 and mfr report number 1066015-2020-00033 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2019-00565.Mfr report number 1066015-2020-00033 is to be considered as deleted.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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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.There were no wrap attribute or variable defects recorded for the batch.The material records for nsw/mj skin contact adhesive laminate (sca); material number # were reviewed.There were three batches of sca used in the manufacturing of the batch, batch 2001027407, 2001045652 and 2001045653.There were no raw material incident forms completed for the batch of sca material.Sca laminate passed all criteria for release for use in manufacturing.This batch reviewed from a manufacturing perspective.There were no investigations associated with this batch for wraps' adhesion.The visual inspection of a retain sample included one carton and one pouched wraps inside.Sample shows no obvious defects.An evaluation of the complaint history confirms that this is the second complaint for the sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause related to the subclass.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 20.This result was below the upper control limit (ucl) of 189.5 complaints per sop# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.The root cause category is non assignable (complaint not confirmed as a quality defect).A wrap was not returned in the returned consumer sample; therefore, the complaint cannot be confirmed.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.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.Summary of investigation: batch aa2375 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve 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).The evaluation of the consumer returned sample did not provide any additional evidence to determine a root cause of the wrap not adhering to consumer during use; there were no defects found on the wraps.After a review of the skin contact adhesive laminate (sca) material records for the batches of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing root cause related to the subclass.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 20.This result was below the upper control limit (ucl) of 189.5 complaints per (b)(4) complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.The sample was received at the site.Return sample evaluation: wrap not returned.Pouch is opened by consumer.No obvious defects.
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Search Alerts/Recalls
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