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| Lot Number W91244 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Irritation (2076); Burning Sensation (2146)
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Event Type
Injury
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Manufacturer Narrative
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Batch/process record review: document review summary: batch w91244 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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.Per lower back and hip 8 hour, thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c).There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the ninth 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 have not been confirmed to have a manufacturing root cause related to the subclass.A visual evaluation was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports , "i have been using this product for a while and then i had to stop using it because it was like irritating my back, burning in my back and my neck area." the cause of the consumer stating the wrap caused irritation and burning 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 is.
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Event Description
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Back all red and sore/hurting me so bad [back pain], back all red and sore [erythema], irritating my back [skin irritation], burning in my back and my neck area [burning sensation], i must be allergic to it [hypersensitivity].Case narrative: this is a spontaneous report from a contactable consumer.This (b)(6) female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number w91244 , expiration date jul2021, udi# (b)(4), from unknown date for back pain.Medical history included thyroid disease, neck surgery.Concomitant medication included an injection (unspecified medication) in back that didn't help.Consumer had been using this product for a while and then she had to stop using it because it was like irritating her back, burning in her back and neck area.She had a neck wrap and the heat wrap around her back and she had back issues and neck issues and she couldn't use this stuff anymore and she didn't know.Her back were all red and sore.She couldn't use that stuff anymore.She had bought lot of these and she was using and using and then it was just irritating her and hurting her so bad and then finally she said she must be allergic to it something going on.Then she stopped using it and she had neck ones too (one time use).She started using them on 50th birthday.She started using them actually like (b)(6).She had a neck surgery and stuff couple of months before.She had lab work a month ago ((b)(6)2019).No treatment was received for the events.She just had to stop using them.The action taken in response to the events of the product was permanently discontinued.The outcome of the events was unknown.Product investigation results were as follows: batch/process record review: document review summary: batch w91244 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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.Per lower back and hip 8 hour, thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c).There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the ninth 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 have not been confirmed to have a manufacturing root cause related to the subclass.A visual evaluation was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports , "i have been using this product for a while and then i had to stop using it because it was like irritating my back, burning in my back and my neck area." the cause of the consumer stating the wrap caused irritation and burning 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.Reasonably suggest device malfunction: no.Site sample status: not received.Additional information has been requested and will be provided as it becomes available.Follow-up (02jul2019): follow-up attempts are completed.No further information is expected.Follow-up (08jan2020): new information reported from product quality complaints includes product investigation report.Follow-up attempts are completed.No further information is expected company clinical evaluation comment: based on the information provided, the events back pain and erythema as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.Comment: based on the information provided, the events back pain and erythema as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.
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Event Description
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Event verbatim [preferred term] back all red and sore/hurting me so bad [back pain] , back all red and sore [erythema] , irritating my back [skin irritation] , burning in my back and my neck area [burning sensation], i must be allergic to it [hypersensitivity].Case narrative:this is a spontaneous report from a contactable consumer.This 51-year-old female consumer started to receive thermacare heatwrap (thermacare lower back & hip) lot number w91244, expiration date jul2021, udi# (b)(4), from unknown date for back pain.Medical history included thyroid disease, neck surgery.Concomitant medication included an injection (unspecified medication) in back that didn't help.Consumer had been using this product for a while and then she had to stop using it because it was like irritating her back, burning in her back and neck area.She had a neck wrap and the heat wrap around her back and she had back issues and neck issues and she couldn't use this stuff anymore and she didn't know.Her back were all red and sore.She couldn't use that stuff anymore.She had bought lot of these and she was using and using and then it was just irritating her and hurting her so bad and then finally she said she must be allergic to it something going on.Then she stopped using it and she had neck ones too (one time use).She started using them on 50th birthday.She started using them actually like (b)(6).She had a neck surgery and stuff couple of months before.She had lab work a month ago (b)(6) 2019.No treatment was received for the events.She just had to stop using them.The action taken in response to the events of the product was permanently discontinued.The outcome of the events was unknown.Product investigation results were as follows: batch/process record review:document review summary: batch w91244 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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.Per lower back and hip 8 hour, thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c).There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the ninth 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 have not been confirmed to have a manufacturing root cause related to the subclass.A visual evaluation was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports , "i have been using this product for a while and then i had to stop using it because it was like irritating my back, burning in my back and my neck area." the cause of the consumer stating the wrap caused irritation and burning 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.Reasonably suggest device malfunction: no.Site sample status: not received.Per pfizer device complaint handling unit (dchu): rsnbly suggest device malfunction was yes and severity of harm was s3 for sub-class: adverse event/serious/unknown.Conclusion: a full investigation was not performed as providing the batch record information is the manufacturing site's requirement.Therefore, a summary investigation was performed.Based on the complaint narrative, the patient experienced of irritating, burning, red, sore back and neck area with product use.Review of complaint description concludes there is no device malfunction.Follow-up (02jul2019): follow-up attempts are completed.No further information is expected.Follow-up (08jan2020): new information reported from product quality complaints includes product investigation report.Follow-up attempts are completed.No further information is expected.Follow-up (22jan2020): new information reported from product quality complaint group included: dchu assessment (malfunction assessment and severity of harm).Company clinical evaluation comment: based on the information provided, the events back pain and erythema as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the information provided, the events back pain and erythema as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The other events are non-serious.The events are medically assessed as associated with the use of the device.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 remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Batch/process record review: document review summary: batch w91244 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.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.Per lower back and hip 8 hour, thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6°c - 41.6°c).There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing and technical perspective.There are no known site investigations associated with this batch.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the ninth 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 have not been confirmed to have a manufacturing root cause related to the subclass.A visual evaluation was performed to identify a potential trend.On the basis of this evaluation, a trend does not exist for this batch.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports , "i have been using this product for a while and then i had to stop using it because it was like irritating my back, burning in my back and my neck area." the cause of the consumer stating the wrap caused irritation and burning 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 is.
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Search Alerts/Recalls
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