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PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT
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| Lot Number X70537 |
| Device Problems
Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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| Event Date 02/01/2019 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] pc- tape doesn't stay on the wraps/does not stick to skin falls off [device adhesion issue], they don't work, they expired in aug) 2017 [device ineffective], they don't work, they expired in aug 2017 [expired device used].Case narrative: this is a spontaneous report from a contactable consumer reported for himself.A (b)(6)-year-old male patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) lot number: x70537, expiry date: aug2017, udi number (b)(4), lot number: x70537, expiry date: jul2021, from unknown date at unknown frequency for pain in right shoulder.Medical history was not reported.There were no concomitant medications.The patient bought thermacare advanced muscle pain therapy on (b)(6) 2019 they didn't work, they expired in aug2017.The stuff that held it on the ends, the tape didn't stay on in (b)(6) 2019.The patient further reported did not stick to skin, fell off.The patient was admitted to hospital for event tape doesn't stay on the wraps.He was not admitted to hospital for other events.No treatment received for any events.The action taken in response to the events of the product was unknown.The outcome of the events was not resolved.Follow-up (19mar2019): new information received from a contactable consumer includes patient data (age), concomitant drug data, device data (indication, expiry date), outcome of events, onset date of events, product complaint details, deny of treatment, hospitalization details and case upgraded to be serious, reportable mdr.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the information provided, the event device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events device ineffective and expired device used are non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the event device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events device ineffective and expired device used are non-serious.The events are medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] pc- tape doesn't stay on the wraps/does not stick to skin falls off [device adhesion issue] , they don't work, they expired in (b)(6) 2017 [device ineffective] , they don't work, they expired in (b)(6) 2017 [expired device used] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for himself.A 71-year-old male patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) lot number: x70537, expiry date: aug2017, udi number (b)(4), lot number: x70537, expiry date: (b)(6) 2021, from unknown date at unknown frequency for pain in right shoulder.Medical history was not reported.There were no concomitant medications.The patient bought thermacare advanced muscle pain therapy on (b)(6) 2019, and in (b)(6) 2019 they didn't work, they expired in aug2017.The stuff that held it on the ends, the tape didn't stay on in feb2019.The patient further reported did not stick to skin, fell off.The patient was admitted to hospital for event tape doesn't stay on the wraps.He was not admitted to hospital for other events.No treatment received for any events.Device was available for evaluation.The action taken in response to the events of the product was unknown.The outcome of the events was not resolved.According to product quality complaint group: investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, loss or deterioration of function per rpt-74091, bridging pfizer hal severity ranking numbers applied in the thermacare heat wrap rmp, effective 28sep2018 section 3.1.2.1.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (b)(6) (2019): new information received from a contactable consumer includes patient data (age), concomitant drug data, device data (indication, expiry date), outcome of events, onset date of events, product complaint details, deny of treatment, hospitalization details and case upgraded to be serious, reportable mdr.Follow-up attempts are completed.No further information is expected.Follow-up (b)(6) (2019): new information received from a product quality complaint group included: investigation results.Follow-up (b)(6) 2019): this is a follow-up report received from the product quality complaint group includes device information and medwatch information updated.Company clinical evaluation comment: based on the information provided, the event device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events device ineffective and expired device used 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 event device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events device ineffective and expired device used 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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Investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, loss or deterioration of function per rpt(b)(4), bridging pfizer hal severity ranking numbers applied in the thermacare heat wrap rmp, effective (b)(6) 2018 section 3.1.2.1.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description 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] pc- tape doesn't stay on the wraps/does not stick to skin falls off [device adhesion issue] , they don't work, they expired in aug 2017 [device ineffective] , they don't work, they expired in aug 2017 [expired device used] ,.Case narrative:this is a spontaneous report from a contactable consumer reported for himself.A 71-year-old male patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) lot number: x70537, expiry date: aug2017, udi number 305733013038, lot number: x70537, expiry date: jul2021, from unknown date at unknown frequency for pain in right shoulder.Medical history was not reported.There were no concomitant medications.The patient bought thermacare advanced muscle pain therapy on 06feb2019, and in feb2019 they didn't work, they expired in aug2017.The stuff that held it on the ends, the tape didn't stay on in feb2019.The patient further reported did not stick to skin, fell off.The patient was admitted to hospital for event tape doesn't stay on the wraps.He was not admitted to hospital for other events.No treatment received for any events.The action taken in response to the events of the product was unknown.The outcome of the events was not resolved.According to product quality complaint group: investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, loss or deterioration of function per rpt-74091, bridging pfizer hal severity ranking numbers applied in the thermacare heat wrap rmp, effective 28sep2018 section 3.1.2.1.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (19mar2019): new information received from a contactable consumer includes patient data (age), concomitant drug data, device data (indication, expiry date), outcome of events, onset date of events, product complaint details, deny of treatment, hospitalization details and case upgraded to be serious, reportable mdr.Follow-up attempts are completed.No further information is expected.Follow-up (03jun2019): new information received from a product quality complaint group included: investigation results.Company clinical evaluation comment: based on the information provided, the event device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events device ineffective and expired device used are non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the event device adhesion issue as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events device ineffective and expired device used are non-serious.The events are medically assessed as associated with the use of the device.
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Manufacturer Narrative
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Investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, loss or deterioration of function per rpt-74091, bridging pfizer hal severity ranking numbers applied in the thermacare heat wrap rmp, effective 28sep2018 section 3.1.2.1.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description 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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Tape doesn't stay on the wraps/does not stick to skin falls off [device adhesion issue].They don't work, they expired in aug 2017 [device ineffective].They don't work, they expired in aug 2017 [expired device used].Case description: this is a spontaneous report from a contactable consumer reported for himself.A 71-year-old male patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: x70537, expiry date: aug2017, udi number (b)(4), lot number: x70537, expiry date: jul2021) from an unknown date at unknown frequency for pain in right shoulder.Medical history was not reported.There were no concomitant medications.The patient bought thermacare advanced muscle pain therapy on 06feb2019, and in (b)(6) 2019 they didn't work, they expired in aug2017.The stuff that held it on the ends, the tape didn't stay on in (b)(6) 2019.The patient further reported did not stick to skin, fell off.The patient was admitted to hospital for event tape doesn't stay on the wraps.He was not admitted to hospital for other events.No treatment received for any events.Device was available for evaluation.Action taken in response to the events of the product was permanently withdrawn on an unspecified date.The outcome of the events was not resolved.Upon follow-up received on 17jun2019, the patient clarified he was not hospitalized as a result of the events.No therapeutic measures were taken as a result of the events.According to product quality complaint group: investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, loss or deterioration of function per (b)(4), bridging pfizer hal severity ranking numbers applied in the thermacare heat wrap rmp, effective 28sep2018 section 3.1.2.1.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (19mar2019): new information received from a contactable consumer includes patient data (age), concomitant drug data, device data (indication, expiry date), outcome of events, onset date of events, product complaint details, deny of treatment,\ hospitalization details and case upgraded to be serious, reportable mdr.Follow-up attempts are completed.No further information is expected.Follow-up (03jun2019): new information received from a product quality complaint group included: investigation results.Follow-up (04jun2019): this is a follow-up report received from the product quality complaint group includes device information and medwatch information updated.Follow-up (17jun2019): new information received from a contactable consumer includes: action taken with suspect product, no therapeutic measures taken and clarification of patient hospitalization (patient was not hospitalized).Case downgraded from serious and reportable.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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Investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, loss or deterioration of function per (b)(4), bridging pfizer hal severity ranking numbers applied in the thermacare heat wrap rmp, effective 28sep2018 section 3.1.2.1.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.
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Manufacturer Narrative
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Investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, loss or deterioration of function per rpt-74091, bridging pfizer hal severity ranking numbers applied in the thermacare heat wrap rmp, effective (b)(6) 2018 section 3.1.2.1.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description 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] tape doesn't stay on the wraps/does not stick to skin falls off [device adhesion issue], they don't work, they expired in aug 2017 [device ineffective], they don't work, they expired in aug 2017 [expired device used], , narrative: this is a spontaneous report from a contactable consumer reported for himself.A 71-year-old male patient started to use thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain) (device lot number: x70537, expiry date: aug2017, udi number (b)(4), lot number: x70537, expiry date: jul2021) from an unknown date at unknown frequency for pain in right shoulder.Medical history was not reported.There were no concomitant medications.The patient bought thermacare advanced muscle pain therapy on (b)(6)2019, and in (b)(6)2019 they didn't work, they expired in aug2017.The stuff that held it on the ends, the tape didn't stay on in (b)(6)2019.The patient further reported did not stick to skin, fell off.The patient was admitted to hospital for event tape doesn't stay on the wraps.He was not admitted to hospital for other events.No treatment received for any events.Device was available for evaluation.Action taken in response to the events of the product was permanently withdrawn on an unspecified date.The outcome of the events was not resolved.Upon follow-up received on 17jun2019, the patient clarified he was not hospitalized as a result of the events.No therapeutic measures were taken as a result of the events.According to product quality complaint group: investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).Sample is not available for evaluation by the site; complaint cannot be confirmed.Notification to safety is not required.A wrap not adhering has a severity of s1, inconvenient, annoying but no harm, loss or deterioration of function per rpt-74091, bridging pfizer hal severity ranking numbers applied in the thermacare heat wrap rmp, effective (b)(6)2018 section 3.1.2.1.After a review of the skin contact adhesive laminate (sca) material records for the batch of sca used in this batch the root cause of why the wraps would not adhere to the body for use is inconclusive since review of records does not provide evidence to support defective product.Sca laminate passed all criteria for release for use in manufacturing.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (19mar2019): new information received from a contactable consumer includes patient data (age), concomitant drug data, device data (indication, expiry date), outcome of events, onset date of events, product complaint details, deny of treatment, hospitalization details and case upgraded to be serious, reportable mdr.Follow-up attempts are completed.No further information is expected.Follow-up (03jun2019): new information received from a product quality complaint group included: investigation results.Follow-up (04jun2019): this is a follow-up report received from the product quality complaint group includes device information and medwatch information updated.Follow-up (17jun2019): new information received from a contactable consumer includes: action taken with suspect product, no therapeutic measures taken and clarification of patient hospitalization (patient was not hospitalized).Case downgraded from serious and reportable.Follow-up attempts are completed.No further information is expected.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number 1066015-2019-00079 and mfr report number 1066015-2019-00196 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2019-00079.Mfr report number 1066015-2019-000196 is to be considered as deleted.
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