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| Lot Number M59552 |
| Device Problems
Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)
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| Patient Problems
Itching Sensation (1943); Skin Discoloration (2074); Skin Irritation (2076); Reaction (2414)
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| Event Date 04/10/2016 |
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Event Type
Injury
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Event Description
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Itchy skin from the glue [pruritus], irritation skin [skin irritation], had signs or a mark from the glue taped edges [skin discolouration].Case narrative: this is a spontaneous report from a contactable consumer (dental hygienist) reported for herself.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number m59552, expiration date sep2018, on (b)(6) 2016 at 10:30 pm for shoulder pain.The patient's medical history was not reported.The patient's concomitant medications were none.The patient applied it from the front to the back of her left shoulder.The glue that adhered to the skin irritated her on (b)(6) 2016, after 30 min of applying.She removed the product in less than an hour (follow-up reported as removed it within 30 mins) because of the skin irritation.The itchiness went away after about ten minutes on (b)(6) 2016.She kept touching the area with her fingers and hands since the night of (b)(6) 2016.She noticed the mark from the glue (b)(6) 2016, washed it and she still had signs or a mark from the glue.She did not want to use the product that had this glue.She felt the heat however due to ends attached by a 'glue' she had to remove it immediately was unable to hold it for the duration of night.She did not notice any damage to product, and it was sealed when purchased.Patient was hospitalized due to the events.No treatment received.The event itchy skin was resolved on (b)(6) 2016, other events were resolved in (b)(6) 2016.Additional information has been requested and will be provided as it becomes available.Follow-up (28apr2016): new information received from the contactable consumer included: product start time, no concomitant medication, events outcome, case upgrade to serious as patient was hospitalized.Follow-up attempts completed.No further information expected.Follow-up (27jun2016): follow-up attempts are completed.No further information is expected.Follow-up (28apr2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the events pruritus, skin irritation and skin discolouration are considered serious medical conditions requiring hospitalization to prevent serious outcome.A causal relationship between the device and the events cannot be ruled out.This case will be re-assessed should additional information becomes available.Comment: based on the available information, the events pruritus, skin irritation and skin discolouration are considered serious medical conditions requiring hospitalization to prevent serious outcome.A causal relationship between the device and the events cannot be ruled out.This case will be re-assessed should additional information becomes available.
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Manufacturer Narrative
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A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.This supplemental report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).
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Manufacturer Narrative
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A sample of the product was available to be returned if requested.The site sample status was: not received.There was no reasonable suggestion of device malfunction.Batch m59552 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Final confirmation status: not confirmed.The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, "the glue that adhered to the skin irritated her." the cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause an adverse event; skin irritation.The visual inspection of a retain sample included one carton with three pouched wraps inside.There were no obvious defects observed.
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Event Description
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Event verbatim [preferred term] itchy skin from the glue [pruritus] , irritation skin [skin irritation] , had signs or a mark from the glue taped edges [skin discolouration] ,.Case narrative:this is a spontaneous report from a contactable consumer (dental hygienist) reported for herself.A 47-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number m59552, expiration date sep2018, on 10apr2016 at 10:30 pm for shoulder pain.The patient's medical history was not reported.The patient's concomitant medications were none.The patient applied it from the front to the back of her left shoulder.The glue that adhered to the skin irritated her on (b)(6) 2016, after 30 min of applying.She removed the product in less than an hour (follow-up reported as removed it within 30 mins) because of the skin irritation.The itchiness went away after about ten minutes on (b)(6) 2016.She kept touching the area with her fingers and hands since the night of (b)(6) 2016.She noticed the mark from the glue (b)(6) 2016, washed it and she still had signs or a mark from the glue.She did not want to use the product that had this glue.She felt the heat however due to ends attached by a 'glue' she had to remove it immediately was unable to hold it for the duration of night.She did not notice any damage to product, and it was sealed when purchased.Patient was hospitalized due to the events.No treatment received.The event itchy skin was resolved on (b)(6) 2016, other events were resolved in (b)(6) 2016.Product quality complaints provided the following investigation info: a sample of the product was available to be returned if requested.The site sample status was: not received.There was no reasonable suggestion of device malfunction.Batch m59552 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Final confirmation status: not confirmed.The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, "the glue that adhered to the skin irritated her." the cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause an adverse event; skin irritation.The visual inspection of a retain sample included one carton with three pouched wraps inside.There were no obvious defects observed.Follow-up (28apr2016): new information received from the contactable consumer included: product start time, no concomitant medication, events outcome, case upgrade to serious as patient was hospitalized.Follow-up attempts completed.No further information expected.Follow-up (27jun2016): follow-up attempts are completed.No further information is expected.Follow-up (28apr2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up attempts are completed.No further information is expected.Follow-up (10jan2020): new information received from a product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the events pruritus, skin irritation and skin discolouration are considered serious medical conditions requiring hospitalization to prevent serious outcome.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time., comment: based on the available information, the events pruritus, skin irritation and skin discolouration are considered serious medical conditions requiring hospitalization to prevent serious outcome.A causal relationship between the device and the events cannot be ruled out.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No further investigations or actions is suggested at this time.
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Event Description
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Event verbatim [preferred term].Itchy skin from the glue [pruritus], irritation skin [skin irritation], had signs or a mark from the glue taped edges [skin discolouration], the glue that adhered to the skin irritated her/ had signs or a mark from the glue [device issue].Narrative: this is a spontaneous report from a contactable consumer (dental hygienist) reported for herself.A 47-year-old female patient started to receive thermacare heatwrap (thermacare neck, shoulder & wrist), device lot number m59552, expiration date sep2018.On (b)(6) 2016 at 10:30 pm for shoulder pain.The patient's medical history was not reported.The patient's concomitant medications were none.The patient applied it from the front to the back of her left shoulder.The glue that adhered to the skin irritated her on (b)(6) 2016, after 30 min of applying.She removed the product in less than an hour (follow-up reported as removed it within 30 mins) because of the skin irritation.The patient experienced itchy skin from the glue on (b)(6) 2016.The itchiness went away after about ten minutes on (b)(6) 2016.She kept touching the area with her fingers and hands since the night of (b)(6) 2016.She noticed the mark from the glue (b)(6) 2016, washed it and she still had signs or a mark from the glue.She did not want to use the product that had this glue.She felt the heat however due to ends attached by a 'glue' she had to remove it immediately was unable to hold it for the duration of night.She did not notice any damage to product, and it was sealed when purchased.Patient was hospitalized due to the events.No treatment received.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2016.The event itchy skin and device issue was resolved on (b)(6) 2016, other events were resolved in (b)(6) 2016.Product quality complaints provided the following investigation info: a sample of the product was available to be returned if requested.The site sample status was: not received.There was no reasonable suggestion of device malfunction.Batch m59552 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Final confirmation status: not confirmed.The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, "the glue that adhered to the skin irritated her." the cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause an adverse event; skin irritation.The visual inspection of a retain sample included one carton with three pouched wraps inside.There were no obvious defects observed.According to product quality complaint group, batch m59552 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).The consumer reports "itchy skin from the glue / irritation skin / had signs or a mark from the glue taped edges." 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 caused "itchy skin from the glue / irritation skin / had signs or a mark from the glue taped edges" 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.The batch expired in sep2018.At the time the complaint was originally reported (b)(6) 2016 the product was within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the fifth 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 was not confirmed to have a manufacturing root cause for the complaint.The complaint was evaluated to identify any potential trend for the lot and subclass.The calculated complaints per million produced (cpmp) result was 21.This result was below control limit (ucl) of 33.9 complaints per sop-# complaint trending guideline, effective (b)(6) 2020.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.Follow-up (28apr2016): new information received from the contactable consumer included: product start time, no concomitant medication, events outcome, case upgrade to serious as patient was hospitalized.Follow-up attempts completed.No further information expected.Follow-up (27jun2016): follow-up attempts are completed.No further information is expected.Follow-up (28apr2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up attempts are completed.No further information is expected.Follow-up (10jan2020): new information received from a product quality complaint group includes: investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (10jun2020): new information received from a product quality complaint group included: investigation results.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: the approximate device age "30 months" is removed and duration for event "itchy skin from the glue" is updated to 10 min.
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Manufacturer Narrative
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A sample of the product was available to be returned if requested.The site sample status was: not received.There was no reasonable suggestion of device malfunction.Batch m59552 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Final confirmation status: not confirmed.The root cause category is non-assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports, "the glue that adhered to the skin irritated her." the cause of the adverse event is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data 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.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.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would cause an adverse event; skin irritation.The visual inspection of a retain sample included one carton with three pouched wraps inside.There were no obvious defects observed.Batch m59552 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The dhr, reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed).The consumer reports "itchy skin from the glue / irritation skin / had signs or a mark from the glue taped edges".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 caused "itchy skin from the glue / irritation skin / had signs or a mark from the glue taped edges" 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.The batch expired in sep2018.At the time the complaint was originally reported (11apr2016) the product was within expiration date.The product quality for the batch is not impacted by this complaint.Lot trend assessment and rationale: an evaluation of the complaint history confirms that this is the fifth complaint for the sub class adverse event safety request for investigation 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.Site sample status was not received.
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