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| Lot Number T81951 |
| Device Problems
Break (1069); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Damaged Prior to Use (2284)
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| Patient Problem
Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] 4 other heatwraps that have fallen apart when they came out of the packaging [device issue], put a heatwrap back together with a stapler and then used the product [intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), via an unspecified route of administration, from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient reported that she was hospitalized as "4 other heatwraps that have fallen apart when they came out of the packaging".She also stated that she "put a heatwrap back together with a stapler and then used the product", which did not require hospitalization or treatment.The patient also reported an unspecified malfunction which did not require hospitalization or treatment.No action was taken with thermacare heatwrap as the patient is still using the product.The lot number and expiration date were not available as the products were discarded.The outcome of the events was not reported.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device., comment: based on the information provided, the event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Manufacturer Narrative
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Initial complaint assessment: batch t81951 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6)2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the second complaint for the sub class came apart/separated/torn (excludes damaged cells) received at the (city name) site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.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.Shiftly transition reports for the batch were reviewed, there was one occurrence of a rash of hook missing rejects, electrical and instrumental colleagues were called to the line to resolve the issue.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The sample is not available at the site for evaluation, the complaint can not 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 vari.
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Event Description
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Event verbatim [preferred term] 4 other heatwraps that have fallen apart when they came out of the packaging [device issue] , put a heatwrap back together with a stapler and then used the product [intentional device misuse] ,.Case narrative:this is a spontaneous report from two contactable consumers.A 93-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), lot number: t81951, expiration date: dec2020, from an unspecified date at unknown frequency for an unspecified indication.Medical history was not reported.There were no concomitant medications.The patient reported that she was hospitalized explained as "4 other heatwraps that have fallen apart when they came out of the packaging" which did not receive treatment.She also stated that she "put a heatwrap back together with a stapler and then used the product", which did not require hospitalization or receive treatment.The patient also reported an unspecified malfunction which did not require hospitalization or treatment.The used products were discarded.The action taken in response to the events for thermacare heatwrap was dose not changed.The patient was still using the product.The outcome of the events was recovered.Per the product quality complaint group: initial complaint assessment: batch t81951 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.Form-46455 retain sample inspection form documented the retain evaluation performed on (b)(6) 2018 for an unrelated complaint.An evaluation of the complaint history confirms that this is the second complaint for the sub class came apart/separated/torn (excludes damaged cells) received at the (city name) site requiring an evaluation for this batch.The previous complaint was not confirmed to have a manufacturing related root cause for the complaint.On the basis of this evaluation, a trend does not exist for this batch.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.Shiftly transition reports for the batch were reviewed, there was one occurrence of a rash of hook missing rejects, electrical and instrumental colleagues were called to the line to resolve the issue.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch.Investigation summary: the root cause category is non-assignable (complaint not confirmed).The sample is not available at the site for evaluation, the complaint can not 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 severity level is s1-negligible; inconvenient, annoying but no harm per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp" version 1.0, effective date: (b)(6) 2018.Follow-up (22mar2019): new information received from the product quality complaint group includes: investigation summary and suspect device data (lot number and expiration date reported).Follow-up (26mar2019): new information reported from two contactable consumers include: concomitant details and event details (updated outcome of event and treatment information).Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: evaluation codes updated.Amendment: this follow-up report is being submitted to amend previously reported information: suspect device was updated from thermacare menstrual to thermacare lower back & hip.Follow-up (29may2019).New information received from the product quality complaint group includes: investigation summary.Company clinical evaluation comment based on the information provided, the event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event intentional device misuse is 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 event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event intentional device misuse is 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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The root cause category is non assignable (complaint not confirmed as a quality defect).The sample is not available by consumer for evaluation by the site; the complaint cannot be confirmed.There is no adverse event mentioned in the intake report.Care should be taken when wearing the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 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.The severity level is s1-negligible; inconvenient, annoying but no harm per rpt-74091 ¿bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp¿, version 1.0, effective date: 28sep2018.
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Event Description
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Event verbatim [preferred term] 4 other heatwraps that have fallen apart when they came out of the packaging [device issue] , put a heatwrap back together with a stapler and then used the product [intentional device misuse].Case narrative: this is a spontaneous report from a contactable consumer.A 93 year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), lot number: t81951, expiration date: dec2020, via an unspecified route of administration, from an unspecified date, for an unspecified indication.Medical history and concomitant medications were not reported.The patient reported that she was hospitalized explained as "4 other heatwraps that have fallen apart when they came out of the packaging".She also stated that she "put a heatwrap back together with a stapler and then used the product", which did not require hospitalization or treatment.The patient also reported an unspecified malfunction which did not require hospitalization or treatment.Per the product quality complaint group: the root cause category is non assignable (complaint not confirmed as a quality defect).The sample is not available by consumer for evaluation by the site; the complaint cannot be confirmed.There is no adverse event mentioned in the intake report.Care should be taken when wearing the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 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.The severity level is s1-negligible; inconvenient, annoying but no harm per (b)(4) "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp" version 1.0, effective date: 28sep2018.No action was taken with thermacare heatwrap as the patient is still using the product.The used products were discarded.The outcome of the events was not reported.Follow-up (22mar2019): new information received from the product quality complaint group includes: investigation summary and suspect device data (lot number and expiration date reported).Company clinical evaluation comment: based on the information provided, the event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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 event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is 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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The root cause category is non assignable (complaint not confirmed as a quality defect).The sample is not available by consumer for evaluation by the site; the complaint cannot be confirmed.There is no adverse event mentioned in the intake report.Care should be taken when wearing the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 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.The severity level is s1-negligible; inconvenient, annoying but no harm per rpt-(b)(4)¿bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp¿, version 1.0, effective date: 28sep2018.
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Event Description
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Event verbatim [preferred term] 4 other heatwraps that have fallen apart when they came out of the packaging [device issue] , put a heatwrap back together with a stapler and then used the product [intentional device misuse] ,.Case narrative:this is a spontaneous report from two contactable consumers.A 93-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), lot number: t81951, expiration date: dec2020, from an unspecified date at unknown frequency for an unspecified indication.Medical history was not reported.There were no concomitant medications.The patient reported that she was hospitalized explained as "4 other heatwraps that have fallen apart when they came out of the packaging" which did not receive treatment.She also stated that she "put a heatwrap back together with a stapler and then used the product", which did not require hospitalization or receive treatment.The patient also reported an unspecified malfunction which did not require hospitalization or treatment.The used products were discarded.The action taken in response to the events for thermacare heatwrap was dose not changed.The patient was still using the product.The outcome of the events was recovered.Per the product quality complaint group: the root cause category is non assignable (complaint not confirmed as a quality defect).The sample is not available by consumer for evaluation by the site; the complaint cannot be confirmed.There is no adverse event mentioned in the intake report.Care should be taken when wearing the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 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.The severity level is s1-negligible; inconvenient, annoying but no harm per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp" version 1.0, effective date: 28sep2018.Follow-up (22mar2019): new information received from the product quality complaint group includes: investigation summary and suspect device data (lot number and expiration date reported).Follow-up (26mar2019): new information reported from two contactable consumers include: concomitant details and event details (updated outcome of event and treatment information).Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to amend previously reported information: evaluation codes updated.Company clinical evaluation comment based on the information provided, the event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event intentional device misuse is 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 event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event intentional device misuse is 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] 4 other heatwraps that have fallen apart when they came out of the packaging [device issue] , put a heatwrap back together with a stapler and then used the product [intentional device misuse] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 93 year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), lot number: t81951, expiration date: dec2020, via an unspecified route of administration, from an unspecified date, for an unspecified indication.Medical history was not reported.Concomitant therapy was none.The patient reported that she was hospitalized explained as "4 other heatwraps that have fallen apart when they came out of the packaging" which did not require treatment.She also stated that she "put a heatwrap back together with a stapler and then used the product", which did not require hospitalization or treatment.The patient also reported an unspecified malfunction which did not require hospitalization or treatment.Per the product quality complaint group: the root cause category is non assignable (complaint not confirmed as a quality defect).The sample is not available by consumer for evaluation by the site; the complaint cannot be confirmed.There is no adverse event mentioned in the intake report.Care should be taken when wearing the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 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.The severity level is s1-negligible; inconvenient, annoying but no harm per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp" version 1.0, effective date: (b)(6) 2018.No action was taken with thermacare heatwrap as the patient is still using the product.The used products were discarded.The outcome of the events was recovered.Follow-up (22mar2019): new information received from the product quality complaint group includes: investigation summary and suspect device data (lot number and expiration date reported).Follow-up (26mar2019): new information reported from two contactable consumers include: concomitant details and event details (updated outcome of event and treatment information).Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event intentional device misuse is 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 event "device issue' with hospitalization as described is considered as serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.Event intentional device misuse is 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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The root cause category is non assignable (complaint not confirmed as a quality defect).The sample is not available by consumer for evaluation by the site; the complaint cannot be confirmed.There is no adverse event mentioned in the intake report.Care should be taken when wearing the device, following all safety and use information as provided with the wrap to avoid the risks of burns or other skin irritations.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 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.The severity level is s1-negligible; inconvenient, annoying but no harm per rpt-74091 ¿bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp¿, version 1.0, effective date: (b)(6) 2018.
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Search Alerts/Recalls
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