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| Lot Number AL7249 |
| Device Problems
Break (1069); Insufficient Heating (1287); Defective Device (2588); Material Protrusion/Extrusion (2979)
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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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Event Description
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The white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged [device issue].Case narrative: this is a spontaneous report from a contactable consumer.This male consumer of unknown age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number al7249, expiration date dec2021, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer had made a habit of using thermacare neck pain therapy wraps almost on a nightly basis.There had been a problem with the last several packages purchased at (specialty pharmacy name) and (pharmacy name).He stated that the cells, when he opened the package, were hard as a rock and didn't produce any heat.The last two nights, he opened a package, the first night, the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom.Last night, he opened the package up and the area across the cells, there was a strip, 1.5 inches wide, there was a red tape that covered the whole thing.He stated that the products had been damaged.It had happened over a couple weeks, maybe longer.Last night, he ran out of the heat wraps.He was unable to find them last night.He did not have lot number and expiration dates for other affected packages.He said that it had happened for the last 6 packages where at least 1 wrap was dead.The sample was available to be returned.Packaging was sealed and intact.He thought there may have been a dent in the box.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the available information, the patient reported that the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged.This is a potential device malfunction.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.The case will be reassessed if relevant additional medical information becomes available.Comment: based on the available information, the patient reported that the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged.This is a potential device malfunction.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.The event is medically assessed as associated with the use of the device.The case will be reassessed if relevant additional medical information becomes available.
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Manufacturer Narrative
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There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hours.Site sample status was not received.Batch al7249 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.Final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available for site evaluation.Complaint cannot be confirmed.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.The root cause for never worked, too cool, did not last 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 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.
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Event Description
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Event verbatim [preferred term] the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.This male consumer of unknown age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number al7249, expiration date dec2021, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer had made a habit of using thermacare neck pain therapy wraps almost on a nightly basis.There had been a problem with the last several packages purchased at (specialty pharmacy name) and (pharmacy name).He stated that the cells, when he opened the package, were hard as a rock and didn't produce any heat.The last two nights, he opened a package, the first night, the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom.Last night, he opened the package up and the area across the cells, there was a strip, 1.5 inches wide, there was a red tape that covered the whole thing.He stated that the products had been damaged.It had happened over a couple weeks, maybe longer.Last night, he ran out of the heat wraps.He was unable to find them last night.He did not have lot number and expiration dates for other affected packages.He said that it had happened for the last 6 packages where at least 1 wrap was dead.The sample was available to be returned.Packaging was sealed and intact.He thought there may have been a dent in the box.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Product quality complaints provided the following information: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hours.Site sample status was not received.Batch al7249 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.Final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available for site evaluation.Complaint cannot be confirmed.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 is as follows for sub-class: wrap/patch/pad never worked/unusable/can not be reused.: the root cause for never worked, too cool, did not last 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 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.Follow-up (07jan2020 and 09jan2020): new information received from a product quality complaint group includes: device malfunction evaluation (reasonable suspicion of a device malfunction, impact is cell leakage) and investigation results.Follow-up (24jan2020): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: based on the available information, the patient reported that the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged.This is a potential device malfunction.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.A causal relationship between the device and event 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 further investigations or actions is suggested at this time., comment: based on the available information, the patient reported that the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged.This is a potential device malfunction.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.A causal relationship between the device and event 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 further investigations or actions is suggested at this time.
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Manufacturer Narrative
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There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hours.Site sample status was not received.Batch al7249 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.Final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available for site evaluation.Complaint cannot be confirmed.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.
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Event Description
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Event verbatim [preferred term] the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged [device issue] ,.Case narrative:this is a spontaneous report from a contactable consumer.This male consumer of unknown age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number al7249, expiration date dec2021, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.Consumer had made a habit of using thermacare neck pain therapy wraps almost on a nightly basis.There had been a problem with the last several packages purchased at (specialty pharmacy name) and (pharmacy name).He stated that the cells, when he opened the package, were hard as a rock and didn't produce any heat.The last two nights, he opened a package, the first night, the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom.Last night, he opened the package up and the area across the cells, there was a strip, 1.5 inches wide, there was a red tape that covered the whole thing.He stated that the products had been damaged.It had happened over a couple weeks, maybe longer.Last night, he ran out of the heat wraps.He was unable to find them last night.He did not have lot number and expiration dates for other affected packages.He said that it had happened for the last 6 packages where at least 1 wrap was dead.The sample was available to be returned.Packaging was sealed and intact.He thought there may have been a dent in the box.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Product quality complaints provided the following information: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- (b)(4) hazard analysis thermacare heat wrap product: 8 and 12 hours.Site sample status was not received.Batch al7249 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.Final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available for site evaluation.Complaint cannot be confirmed.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.Additional information has been requested and will be provided as it becomes available.Follow-up (07jan2020 and 09jan2020): new information received from a product quality complaint group includes: device malfunction evaluation (reasonable suspicion of a device malfunction, impact is cell leakage) and investigation results.Company clinical evaluation comment: based on the available information, the patient reported that the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged.This is a potential device malfunction.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.A causal relationship between the device and event 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 further investigations or actions is suggested at this time., comment: based on the available information, the patient reported that the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged.This is a potential device malfunction.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.A causal relationship between the device and event 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 further investigations or actions is suggested at this time.
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Event Description
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Event verbatim [preferred term] the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged [device issue], , narrative: this is a spontaneous report from a contactable consumer.This male consumer of unknown age started to receive thermacare heatwrap (thermacare neck, shoulder & wrist) lot number al7249, expiration date dec2021, from an unspecified date at unknown frequency for an unspecified indication.Medical history and concomitant medications were not reported.Consumer had made a habit of using thermacare neck pain therapy wraps almost on a nightly basis.There had been a problem with the last several packages purchased at (specialty pharmacy name) and (pharmacy name).He stated that the cells, when he opened the package, were hard as a rock and didn't produce any heat.The last two nights, he opened a package, the first night, the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom.Last night, he opened the package up and the area across the cells, there was a strip, 1.5 inches wide, there was a red tape that covered the whole thing.He stated that the products had been damaged.It had happened over a couple weeks, maybe longer.Last night, he ran out of the heat wraps.He was unable to find them last night.He did not have lot number and expiration dates for other affected packages.He said that it had happened for the last 6 packages where at least 1 wrap was dead.The sample was available to be returned.Packaging was sealed and intact.He thought there may have been a dent in the box.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Product quality complaints provided the following information: there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hours.Site sample status was not received.Batch #: al7249; brand code/sku#: f00573301502x; product count: 3 count ; date of manufacture: 20jan2019 through 26jan2019.Batch al7249 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.Final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available for site evaluation.Complaint cannot be confirmed.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 first complaint for the sub class unidentifiable material in contact with product for this batch.On the basis of this evaluation, a trend does not exist for this batch.Summary is as follows for sub-class: wrap/patch/pad never worked/unusable/can not be reused.: the root cause for never worked, too cool, did not last 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 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.Follow-up (07jan2020 and 09jan2020): new information received from a product quality complaint group includes: device malfunction evaluation (reasonable suspicion of a device malfunction, impact is cell leakage) and investigation results.Follow-up (24jan2020): new information received from a product quality complaint group included: investigation results.Follow-up (24feb2020): follow-up attempts are completed.No further information is expected.Follow-up (08oct2020): new information received from a product quality complaint group included: additional investigation results., comment: based on the available information, the patient reported that the white covering over the cells was rolled down and the cells were exposed.The film over the top was stuck to the bottom/ the products had been damaged.This is a potential device malfunction.There was "no adverse reaction" such as burn associated with the use of the device.This malfunction has a theoretical risk to cause skin burn.A causal relationship between the device and event 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 further investigations or actions is suggested at this time.
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Manufacturer Narrative
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There is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3-skin burn- per rpt- 38832 hazard analysis thermacare heat wrap product: 8 and 12 hours.Site sample status was not received.Batch #: al7249; brand code/sku#: f00573301502x; product count: 3 count ; date of manufacture: 20jan2019 through 26jan2019.Batch al7249 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.Final confirmation status was not confirmed.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).A return sample is not available for site evaluation.Complaint cannot be confirmed.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 first complaint for the sub class unidentifiable material in contact with product for this batch.On the basis of this evaluation, a trend does not exist for this batch.The root cause for never worked, too cool, did not last 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 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.
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Search Alerts/Recalls
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