|
|
| Lot Number DC9524 |
| Device Problems
Device Damaged Prior to Use (2284); Material Deformation (2976)
|
| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
|
Event Type
malfunction
|
|
Event Description
|
|
Themacare all black beads inside [device breakage].Narrative: this is a spontaneous report from a contactable consumer (patient's husband).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare heatwrap) 16 hour pain relief, 'box of 2/ both packages the same device lot number dc9524 10/28 , expiration date sep2022 via an unspecified route of administration for many years from an unspecified date and ongoing as needed for back pain.The patient medical history and concomitant medications were not reported.Consumer purchases thermacare heat wraps for his wife.'everything was sealed and the box looked like every other box they have bought'.When he opened the package and it was all black beads inside.The black pellets were falling all over the floor.It seemed to be already open and it couldn't be used.No one used it.States this is very unusual.Consumer requested a refund.A sample of the product is available to be returned but the box was discarded.Consumer also stated the 'packaging was sealed and intact'.The action taken in response to the event was ongoing.The clinical outcome of the event was unknown.Additional information has been requested and will be provided as it becomes available.Product strength and count size dispensed: box of 2/ both packages the same.Packaging sealed and intact? yes.No follow-up attempts are needed.No further information is expected.
|
| |
|
Event Description
|
|
Pc: themacare all black beads inside/the wrap material wasn't sealed and the cell ingredients fell out [device leakage], narrative: this is a spontaneous report from a contactable consumer (patient's husband).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) 16 hour pain relief, device lot number dc9524, expiration date 30sep2022, via an unspecified route of administration for many years from an unspecified date and ongoing as needed for back pain.The patient medical history and concomitant medications were not reported.Consumer purchased thermacare heat wraps for his wife.Everything was sealed and the box looked like every other box they had bought.When he opened the package and it was all black beads inside.The black pellets were falling all over the floor.It seemed to be already open and it couldn't be used.No one used it.Consumer stated this was very unusual.With this one, the seams were open and stuff came spewing out.There was nothing wrong with the box when they opened it.Consumer requested a refund for thermacare lower back.He reported the wrap material wasn't sealed and the cell ingredients fell out.He also stated the time stamp on the wrap is 10:15 but the time stamp on the box is 10:18.A sample of the product was available to be returned but the box was discarded.Consumer also stated the 'packaging was sealed and intact'.The action taken in response to the event was ongoing.The clinical outcome of the event was unknown.According to product quality complaints, there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3- skin burn-per rpt-# hazard analysis thermacare heat wrap product: 8 and 12 hour.According to the product quality complaint group (site investigation): summary of investigation: date of manufacture: 28oct2019 to 31oct2019; expiry date: 30sep2022; quantity release: (b)(4) cartons.Batch dc9524 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 return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class heat cells damaged/leaking received at the (site name) 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 of 10 was below the upper control limit (ucl) of 25.2 complaints per sop-# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.Amendment: this follow-up report is being submitted to allow appropriate reporting to health authorities.Additional information received on 21oct2020 and 23oct2020 from product quality complaints included: product trade name updated to thermacare lower back & hip, lot number and expiry date, additional event details (event term updated to device leakage) and severity of harm was provided as s3.Follow-up (26oct2020): new information received from the product quality complaint group included investigational results.
|
| |
|
Manufacturer Narrative
|
|
Summary of investigation: date of manufacture: 28oct2019 to 31oct2019; expiry date: 30sep2022; quantity release: (b)(4) cartons.Batch dc9524 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 return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class heat cells damaged/leaking received at the (site name) 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 of 10 was below the upper control limit (ucl) of 25.2 complaints per sop-# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.
|
| |
|
Event Description
|
|
Event verbatim [preferred term], pc: themacare all black beads inside/the wrap material wasn't sealed and the cell ingredients fell out [device leakage], narrative: this is a spontaneous report from a contactable consumer (patient's husband).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) 16 hour pain relief, device lot number dc9524, expiration date 30sep2022, via an unspecified route of administration for many years from an unspecified date and ongoing as needed for back pain.The patient medical history and concomitant medications were not reported.Consumer purchased thermacare heat wraps for his wife.Everything was sealed and the box looked like every other box they had bought.When he opened the package and it was all black beads inside.The black pellets were falling all over the floor.It seemed to be already open and it couldn't be used.No one used it.Consumer stated this was very unusual.With this one, the seams were open and stuff came spewing out.There was nothing wrong with the box when they opened it.Consumer requested a refund for thermacare lower back.He reported the wrap material wasn't sealed and the cell ingredients fell out.He also stated the time stamp on the wrap is 10:15 but the time stamp on the box is 10:18.A sample of the product was available to be returned but the box was discarded.Consumer also stated the 'packaging was sealed and intact'.The action taken in response to the event was unknown.The clinical outcome of the event was unknown.According to product quality complaints, there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3- skin burn-per rpt-# hazard analysis thermacare heat wrap product: 8 and 12 hour.According to the product quality complaint group (site investigation): summary of investigation: date of manufacture: 28oct2019 to 31oct2019; expiry date: 30sep2022; quantity release: (b)(4) cartons.Batch dc9524 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 return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class heat cells damaged/leaking received at the (site name) 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 of 10 was below the upper control limit (ucl) of 25.2 complaints per sop-# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.According to the product quality complaint group for complaint sub-class: primary container damage/defect not classified: severity of harm was provided as s1.Summary was provided as follows: 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 sea completely (open pouch) an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heat ng 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.According to the product quality complaint group, the consumer returned sample has been received at the site and shows evidence of a device malfunction.The site investigation is in process.Amendment: this follow-up report is being submitted to allow appropriate reporting to health authorities.Additional information received on 21oct2020 and 23oct2020 from product quality complaints included: product trade name updated to thermacare lower back & hip, lot number and expiry date, additional event details (event term updated to device leakage) and severity of harm was provided as s3.Follow-up (26oct2020): new information received from the product quality complaint group included investigational results.No follow up attempts are needed.No further information is expected.Follow-up (03nov2020): new information received from the product quality complaint group included investigational results for complaint sub-class: primary container damage/defect not classified.No follow up attempts are needed.No further information is expected.Follow-up (11nov2020): new information received from the product quality complaint group included: returned sample has been received at the site and site investigation is in process.No follow-up attempts are needed.No further information is expected.
|
| |
|
Manufacturer Narrative
|
|
Summary of investigation: date of manufacture: 28oct2019 to 31oct2019; expiry date: 30sep2022; quantity release: (b)(4) cartons.Batch dc9524 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 return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class heat cells damaged/leaking received at the (site name) 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 of 10 was below the upper control limit (ucl) of 25.2 complaints per sop-# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.For complaint sub-class: primary container damage/defect not classified: severity of harm was provided as s1.Summary was provided as follows: 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 sea completely (open pouch) an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heat ng 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.
|
| |
|
Manufacturer Narrative
|
|
Summary of investigation: date of manufacture: 28oct2019 to 31oct2019; expiry date: 30sep2022; quantity release:(b)(4) cartons.Batch dc9524 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 return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class heat cells damaged/leaking received at the (site name) 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 of 10 was below the upper control limit (ucl) of 25.2 complaints per sop-# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.According to the product quality complaint group for complaint sub-class: primary container damage/defect not classified: severity of harm was provided as s1.Summary was provided as follows: 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 sea completely (open pouch) an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heat ng 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.Site sample status was not received.
|
| |
|
Event Description
|
|
Event verbatim [preferred term], pc: themacare all black beads inside/the wrap material wasn't sealed and the cell ingredients fell out [device leakage], , narrative: this is a spontaneous report from a contactable consumer (patient's husband).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) 16 hour pain relief, device lot number dc9524, expiration date 30sep2022, via an unspecified route of administration for many years from an unspecified date and ongoing as needed for back pain.The patient medical history and concomitant medications were not reported.Consumer purchased thermacare heat wraps for his wife.Everything was sealed and the box looked like every other box they had bought.When he opened the package and it was all black beads inside.The black pellets were falling all over the floor.It seemed to be already open and it couldn't be used.No one used it.Consumer stated this was very unusual.With this one, the seams were open and stuff came spewing out.There was nothing wrong with the box when they opened it.Consumer requested a refund for thermacare lower back.He reported the wrap material wasn't sealed and the cell ingredients fell out.He also stated the time stamp on the wrap is 10:15 but the time stamp on the box is 10:18.A sample of the product was available to be returned but the box was discarded.Consumer also stated the 'packaging was sealed and intact'.The action taken in response to the event was unknown.The clinical outcome of the event was unknown.According to product quality complaints, there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3- skin burn-per rpt-# hazard analysis thermacare heat wrap product: 8 and 12 hour.According to the product quality complaint group (site investigation): summary of investigation: date of manufacture: 28oct2019 to 31oct2019; expiry date: 30sep2022; quantity release: (b)(4) cartons.Batch dc9524 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 return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class heat cells damaged/leaking received at the (site name) 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 of 10 was below the upper control limit (ucl) of 25.2 complaints per sop-# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.According to the product quality complaint group for complaint sub-class: primary container damage/defect not classified: severity of harm was provided as s1.Summary was provided as follows: 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 sea completely (open pouch) an open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heat ng 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.Site sample status was not received.Amendment: this follow-up report is being submitted to allow appropriate reporting to health authorities.Additional information received on 21oct2020 and 23oct2020 from product quality complaints included: product trade name updated to thermacare lower back & hip, lot number and expiry date, additional event details (event term updated to device leakage) and severity of harm was provided as s3.Follow-up (26oct2020): new information received from the product quality complaint group included investigational results.No follow up attempts are needed.No further information is expected.Follow-up (03nov2020): new information received from the product quality complaint group included investigational results for complaint sub-class: primary container damage/defect not classified.No follow up attempts are needed.No further information is expected.
|
| |
|
Event Description
|
|
Event verbatim [preferred term], pc: themacare all black beads inside/the wrap material wasn't sealed and the cell ingredients fell out [device leakage], , narrative: this is a spontaneous report from a contactable consumer (patient's husband).A female patient of an unspecified age started to receive thermacare heatwrap (thermacare lower back & hip) 16 hour pain relief, device lot number dc9524, expiration date 30sep2022, via an unspecified route of administration for many years from an unspecified date and ongoing as needed for back pain.The patient medical history and concomitant medications were not reported.Consumer purchased thermacare heat wraps for his wife.Everything was sealed and the box looked like every other box they had bought.When he opened the package and it was all black beads inside.The black pellets were falling all over the floor.It seemed to be already open and it couldn't be used.No one used it.Consumer stated this was very unusual.With this one, the seams were open and stuff came spewing out.There was nothing wrong with the box when they opened it.Consumer requested a refund for thermacare lower back.He reported the wrap material wasn't sealed and the cell ingredients fell out.He also stated the time stamp on the wrap is 10:15 but the time stamp on the box is 10:18.A sample of the product was available to be returned but the box was discarded.Consumer also stated the 'packaging was sealed and intact'.The action taken in response to the event was ongoing.The clinical outcome of the event was unknown.According to product quality complaints, there is reasonable suspicion of a device malfunction.The impact is cell leakage and the severity is s3- skin burn-per rpt-# hazard analysis thermacare heat wrap product: 8 and 12 hour.According to the product quality complaint group (site investigation): summary of investigation: date of manufacture: 28oct2019 to 31oct2019; expiry date: 30sep2022; quantity release: (b)(4) cartons.Batch dc9524 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 return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class heat cells damaged/leaking received at the (site name) 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 of 10 was below the upper control limit (ucl) of 25.2 complaints per sop-# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.Amendment: this follow-up report is being submitted to allow appropriate reporting to health authorities.Additional information received on 21oct2020 and 23oct2020 from product quality complaints included: product trade name updated to thermacare lower back & hip, lot number and expiry date, additional event details (event term updated to device leakage) and severity of harm was provided as s3.Follow-up (26oct2020): new information received from the product quality complaint group included investigational results.No follow up attempts are needed.No further information is expected.
|
| |
|
Manufacturer Narrative
|
|
Summary of investigation: date of manufacture: 28oct2019 to 31oct2019; expiry date: 30sep2022; quantity release: (b)(4) cartons.Batch dc9524 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 return sample is not available from consumer for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.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.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class heat cells damaged/leaking received at the (site name) 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 of 10 was below the upper control limit (ucl) of 25.2 complaints per sop-# complaint trending guideline, effective 24feb2020.On the basis of this evaluation, a trend does not exist for this batch.Site sample status was not received.
|
| |
|
Search Alerts/Recalls
|
|
|
