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| Lot Number M74983 |
| Device Problems
Loose or Intermittent Connection (1371); Device Slipped (1584); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); Device Handling Problem (3265)
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| Patient Problems
Pain (1994); Burn, Thermal (2530)
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| Event Date 04/11/2016 |
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Event Type
Injury
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Event Description
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Getting burn on it [thermal burn].She taped it [intentional device misuse].They do not stick to her underwear; it was so loose it kept falling off, somewhat defective/it did not stick to her underwear [device adhesion issue].Case description: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number m74983, expiration date sep2018, on (b)(6) 2016 for pelvic pain, thermacare heatwrap (thermacare lower back & hip, reported as thermacare back pain therapy) with unspecified usage information for back pain, 1 in 1 day, 8 hours.Medical history included stomach issues because of back pain from an unknown date and hearing impaired.She was retired on social security disability.Post-menopausal.The patient's concomitant medications included unspecified products.The patient reported this was first time it happened; she loved all the products.She bought two boxes of thermacare heat wraps for menstrual pain and they were just terrible and they do not stick to her underwear, the product is somewhat defective.She tried to put it on her skin and ended up getting burn on it on (b)(6) 2016.She reported that they do work when they (thermacare) were on but when she go to the bathroom couples of times they fall off.She mentioned that it was so loose it kept falling off so she taped it, but it did not helped much.She was not supposed to use over the jeans because it would be tight.Events were occurred on (b)(6) 2016 with outcome of unknown.Patient used neosporin.Patient reported hospitalized due to "they do not stick to her underwear; it was so loose it kept falling off; somewhat defective"(pending clarify).Patient had medium skin tone, (neither light nor dark); no sensitive skin, have no abnormal skin conditions; previously used other heat products for pain relief, did not experience a problem/symptom with one of these products.Did not engage in exercise while using the product; did check skin under the product while wearing thermacare; read the usage instructions on thermacare before used the product.The product was stopped after the 2 boxes.Additional information has been requested and will be provided as it becomes available.Follow-up (06may2016): new information reported from a contactable consumer included: medical history.Follow-up (06may2016): new information reported from a contactable consumer included: new suspect product thermacare back pain therapy.Follow-up (17may2016): new information reported from a contactable consumer included: product indication.Patient reported hospitalized due to "they do not stick to her underwear; it was so loose it kept falling off; somewhat defective".Event outcome.Treatment information.Case has been upgraded to serious.Company clinical evaluation comment based on the information provided, the events thermal burn and intentional device misuse as described in this case are considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product adhesion issue assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn and intentional device misuse as described in this case are considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product adhesion issue assessed as associated with the device.This case meets initial 10-day eu and 30-day fda reportability.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number m74983, expiration date sep2018, on (b)(6) 2016 for pain/pelvic pain, thermacare heatwrap (thermacare lower back & hip, reported as thermacare back pain therapy) with unspecified usage information for back pain, 1 in 1 day, 8 hours.Medical history included stomach issues because of back pain from an unknown date and hearing impaired.She was retired on social security disability.Post-menopausal.The patient's concomitant medications included unspecified products.The patient reported this was first time it happened; she loved all the products.She bought two boxes of thermacare heat wraps for menstrual pain and they were just terrible and they do not stick to her underwear, the product is somewhat defective.She tried to put it on her skin and ended up getting burn on it on (b)(6) 2016.She reported that they do work when they (thermacare) were on but when she go to the bathroom couples of times they fall off.She mentioned that it was so loose it kept falling off so she taped it, but it did not helped much.She was not supposed to use over the jeans because it would be tight.Events were occurred on (b)(6) 2016 with outcome of unknown.Patient used neosporin.Patient reported hospitalized due to "they do not stick to her underwear; it was so loose it kept falling off; somewhat defective" (pending clarify).Patient had medium skin tone, (neither light nor dark); no sensitive skin, have no abnormal skin conditions; previously used other heat products for pain relief, did not experience a problem/symptom with one of these products.Did not engage in exercise while using the product; did check skin under the product while wearing thermacare; read the usage instructions on thermacare before used the product.The product was stopped after the 2 boxes.Additional information has been requested and will be provided as it becomes available.Follow-up (06may2016): new information reported from a contactable consumer included: medical history.Follow-up (06may2016): new information reported from a contactable consumer included: new suspect product thermacare back pain therapy.Follow-up (17may2016): new information reported from a contactable consumer included: product indication.Patient reported hospitalized due to "they do not stick to her underwear; it was so loose it kept falling off; somewhat defective".Event outcome.Treatment information.Case has been upgraded to serious.Follow-up (31may2016): new information reported from a contactable consumer included: product indication.Company clinical evaluation comment based on the information provided, the events thermal burn and intentional device misuse as described in this case are considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product adhesion issue assessed as associated with the device.This case meets follow up (b)(6) and 30-day fda reportability.Case comment: based on the information provided, the events thermal burn and intentional device misuse as described in this case are considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product adhesion issue assessed as associated with the device.This case meets follow up (b)(6) and 30-day fda reportability.
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Manufacturer Narrative
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The root cause is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.A review of quality and manufacturing 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 and technical 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.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer.A (b)(6) caucasian female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: m74983, expiration date: sep2018) on (b)(6) 2016 for pain/pelvic pain and thermacare heatwrap (thermacare lower back & hip) from an unspecified date with unspecified usage information for back pain, 1 in 1 day, 8 hours.Medical history included stomach issues because of back pain from an unknown date and hearing impaired from an unknown date.She was retired on (b)(6).The patient was post-menopausal.Concomitant medications included unspecified products.The patient reported she bought two boxes of thermacare heatwraps for menstrual pain and they were just terrible and they do not stick to her underwear.She stated the product is somewhat defective.She tried to put it on her skin and ended up getting burned on (b)(6) 2016.The patient reported she was hospitalized on an unspecified date due to "they do not stick to her underwear; it was so loose it kept falling off; somewhat defective".She reported the heatwraps do work when they were on, but when she went to the bathroom a couples of times they fell off.She mentioned that it was so loose it kept falling off so she taped it, but it did not help much.She was not supposed to use over the jeans because it would be tight.Patient had medium skin tone, (neither light nor dark).She denied having sensitive skin or any abnormal skin conditions.The patient previously used other heat products for pain relief.She did not experience a problem/symptom with any of these products.The patient did not engage in exercise while using the product.She did check the skin under the product while wearing the heatwraps.The patient read the usage instructions on thermacare before she used the product.Action taken with the suspect product was permanently withdrawn on an unspecified date.Therapeutic measures taken included neosporin.Clinical outcome of the events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.The root cause is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.A review of quality and manufacturing 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 and technical 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.Additional information has been requested and will be provided as it becomes available.Follow-up (06may2016): new information reported from a contactable consumer included: medical history.Follow-up (06may2016): new information reported from a contactable consumer included: new suspect product thermacare back pain therapy.Follow-up (17may2016): new information reported from a contactable consumer included: product indication.Patient reported hospitalized due to "they do not stick to her underwear; it was so loose it kept falling off; somewhat defective".Event outcome.Treatment information.Case has been upgraded to serious.Follow-up (31may2016): new information reported from a contactable consumer included: product indication.Follow-up (06jul2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Company clinical evaluation comment: based on the information provided, the events thermal burn and intentional device misuse as described in this case are considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product adhesion issue assessed as associated with the device.This case meets follow up 10-day eu and 30-day fda reportability.Evaluation summary: the root cause is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.A review of quality and manufacturing 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 and technical 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.
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Event Description
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Case description: this is a spontaneous report from a contactable consumer.A (b)(6) year-old caucasian female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: m74983, expiration date: sep2018) on (b)(6) 2016 for pain/pelvic pain 1x/day and thermacare heatwrap (thermacare lower back & hip) from an unspecified date with unspecified usage information for lower back pain, 1 in 1 day, 8 hours.Medical history included stomach issues because of back pain from an unknown date and hearing impaired from an unknown date.She was retired on (b)(6).The patient was post-menopausal.Concomitant medications included unspecified products.The patient reported she bought two boxes of thermacare heatwraps for menstrual pain and they were just terrible and they do not stick to her underwear.She stated the product is somewhat defective.She tried to put it on her skin and ended up getting burned on (b)(6) 2016.The patient reported she was not hospitalized due to the events.She reported the heatwraps do work when they were on, but when she went to the bathroom a couples of times they fell off.She mentioned that it was so loose it kept falling off so she taped it, but it did not help much.She was not supposed to use over the jeans because it would be tight.Patient had medium skin tone, (neither light nor dark).She denied having sensitive skin or any abnormal skin conditions.The patient previously used other heat products for pain relief.She did not experience a problem/symptom with any of these products.The patient did not engage in exercise while using the product.She did check the skin under the product while wearing the heatwraps.The patient read the usage instructions on thermacare before she used the product.Action taken with the suspect products was permanently withdrawn on an unspecified date.Therapeutic measures taken included neosporin.Clinical outcome of the events was resolved on an unspecified date.Additional information received from product quality complaint (pqc) group included investigation results.The root cause is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.A review of quality and manufacturing 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 and technical 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.Additional information has been requested and will be provided as it becomes available.Follow-up (06may2016): new information reported from a contactable consumer included: medical history.Follow-up (06may2016): new information reported from a contactable consumer included: new suspect product thermacare back pain therapy.Follow-up (17may2016): new information reported from a contactable consumer included: product indication.Patient reported hospitalized due to "they do not stick to her underwear; it was so loose it kept falling off; somewhat defective".Event outcome.Treatment information.Case has been upgraded to serious.Follow-up (31may2016): new information reported from a contactable consumer included: product indication.Follow-up (06jul2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (11jul2016): new information received from a contactable consumer included product data (frequency of thermacare menstrual and action taken with both products), and reaction data (outcome of events and clarification regarding hospitalization, the patient was not hospitalized due to the events).Company clinical evaluation comment based on the information provided, the events thermal burn and intentional device misuse as described in this case are considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product adhesion issue assessed as associated with the device.This case meets final 10-day eu and 30-day fda reportability.Follow-up attempts completed.No further information expected.Case comment: based on the information provided, the events thermal burn and intentional device misuse as described in this case are considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product adhesion issue assessed as associated with the device.This case meets final 10-day eu and 30-day fda reportability.
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Manufacturer Narrative
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The root cause is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.A review of quality and manufacturing 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 and technical 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.Additional information received from pqc group on (b)(6) 2020 included additional investigation results.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.After a review of the atex smms menstrual material records for the batches of menstrual laminate used in this batch, the root cause of why the wraps would not adhere for use is inconclusive since review of records does not provide evidence to support defective product.The menstrual material 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.The product was within expiration date at the time the complaint was received; the product expired on 30sep2018.The product quality for the batch is not impacted by this complaint.An evaluation of the complaint history confirms that this is the first complaint for t he sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The complaints was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 11.This result was below the upper control limit (ucl) of 189.5 complaints.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Reasonably suggest device malfunction? yes.Severity of harm: s1.Site sample status: not received.
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Event Description
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Event verbatim [preferred term] getting burn on it [thermal burn], she taped it, read the usage instructions on thermacare before she used the product [intentional device misuse], they do not stick to her underwear; it was so loose it kept falling off, somewhat defective/it did not stick to her underwear [device adhesion issue], , narrative: this is a spontaneous report from a contactable consumer.A 66-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: m74983, expiration date: sep2018) on (b)(6) 2016 for pain/pelvic pain 1x/day and thermacare heatwrap (thermacare lower back & hip) from an unspecified date with unspecified usage information for lower back pain, 1 in 1 day, 8 hours.Medical history included stomach issues because of back pain from an unknown date and hearing impaired from an unknown date.She was retired on social security disability.The patient was post-menopausal.Concomitant medications included unspecified products.The patient reported she bought two boxes of thermacare heatwraps for menstrual pain and they were just terrible and they do not stick to her underwear.She stated the product is somewhat defective.She tried to put it on her skin and ended up getting burned on (b)(6) 2016.The patient reported she was not hospitalized due to the events.She reported the heatwraps do work when they were on, but when she went to the bathroom a couples of times they fell off.She mentioned that it was so loose it kept falling off so she taped it, but it did not help much.She was not supposed to use over the jeans because it would be tight.Patient had medium skin tone, (neither light nor dark).She denied having sensitive skin or any abnormal skin conditions.The patient previously used other heat products for pain relief.She did not experience a problem/symptom with any of these products.The patient did not engage in exercise while using the product.She did check the skin under the product while wearing the heatwraps.The patient read the usage instructions on thermacare before she used the product.Action taken with the suspect products was permanently withdrawn on an unspecified date.Therapeutic measures taken included neosporin.Clinical outcome of the events was resolved on an unspecified date.Additional information received from product quality complaint (pqc) group included investigation results.The root cause is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.A review of quality and manufacturing 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 and technical 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.Additional information received from pqc group on (b)(6) 2020 included additional investigation results.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.After a review of the atex smms menstrual material records for the batches of menstrual laminate used in this batch, the root cause of why the wraps would not adhere for use is inconclusive since review of records does not provide evidence to support defective product.The menstrual material 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.The product was within expiration date at the time the complaint was received; the product expired on (b)(6) 2018.The product quality for the batch is not impacted by this complaint.An evaluation of the complaint history confirms that this is the first complaint for t he sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The complaints was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 11.This result was below the upper control limit (ucl) of 189.5 complaints.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Reasonably suggest device malfunction? yes.Severity of harm: s1.Site sample status: not received.Follow-up (b)(6) 2016): new information reported from a contactable consumer included: medical history.Follow-up (b)(6) 2016): new information reported from a contactable consumer included: new suspect product thermacare back pain therapy.Follow-up (b)(6) 2016: new information reported from a contactable consumer included: product indication.Patient reported hospitalized due to "they do not stick to her underwear; it was so loose it kept falling off; somewhat defective".Event outcome.Treatment information.Case has been upgraded to serious.Follow-up (31may2016): new information reported from a contactable consumer included: product indication.Follow-up (06jul2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (11jul2016): new information received from a contactable consumer included product data (frequency of thermacare menstrual and action taken with both products), and reaction data (outcome of events and clarification regarding hospitalization, the patient was not hospitalized due to the events).Followup (22may2020): new information received from product quality complaints (pqc) group included: additional product quality investigation results.Followup attempts completed.No further information expected.Comment: based on the information provided, the events thermal burn and intentional device misuse as described in this case are considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product adhesion issue assessed as associated with the device.This case meets final 10-day eu and 30-day fda reportability.
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Event Description
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Event verbatim [preferred term] getting burn on it [thermal burn], she taped it, read the usage instructions on thermacare before she used the product [intentional device misuse], they do not stick to her underwear; it was so loose it kept falling off, somewhat defective/it did not stick to her underwear [device adhesion issue], , narrative: this is a spontaneous report from a contactable consumer.A 66-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: m74983, expiration date: sep2018) on 11apr2016 for pain/pelvic pain 1x/day medical history included stomach issues because of back pain from an unknown date and hearing impaired from an unknown date.She was retired on social security disability.The patient was post-menopausal.Concomitant medications included unspecified products.The patient reported she bought two boxes of thermacare heatwraps for menstrual pain and they were just terrible and they do not stick to her underwear.She stated the product is somewhat defective.She tried to put it on her skin and ended up getting burned on 11apr2016.The patient reported she was not hospitalized due to the events.She reported the heatwraps do work when they were on, but when she went to the bathroom a couples of times they fell off.She mentioned that it was so loose it kept falling off so she taped it, but it did not help much.She was not supposed to use over the jeans because it would be tight.Patient had medium skin tone, (neither light nor dark).She denied having sensitive skin or any abnormal skin conditions.The patient previously used other heat products for pain relief.She did not experience a problem/symptom with any of these products.The patient did not engage in exercise while using the product.She did check the skin under the product while wearing the heatwraps.The patient read the usage instructions on thermacare before she used the product.Action taken with the suspect products was permanently withdrawn on an unspecified date.Therapeutic measures taken included neosporin.Clinical outcome of the events was resolved on an unspecified date.Additional information received from product quality complaint (pqc) group included investigation results.The root cause is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.A review of quality and manufacturing 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 and technical 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.Additional information received from pqc group on 22may2020 included additional investigation results.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.After a review of the atex smms menstrual material records for the batches of menstrual laminate used in this batch, theroot cause of why the wraps would not adhere for use is inconclusive since review of records does not provide evidence to support defective product.The menstrual material 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.The product was within expiration date at the time the complaint was received; the product expired on 30sep2018.The product quality for the batch is not impacted by this complaint.An evaluation of the complaint history confirms that this is the first complaint for t he sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The complaints was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 11.This result was below the upper control limit (ucl) of 189.5 complaints.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Reasonably suggest device malfunction? yes.Severity of harm: s1.Site sample status: not received.Follow-up (06may2016): new information reported from a contactable consumer included: medical history.Follow-up (06may2016): new information reported from a contactable consumer included: new suspect product thermacare back pain therapy.Follow-up (17may2016): new information reported from a contactable consumer included: product indication.Patient reported hospitalized due to "they do not stick to her underwear; it was so loose it kept falling off; somewhat defective".Event outcome.Treatment information.Case has been upgraded to serious.Follow-up (31may2016): new information reported from a contactable consumer included: product indication.Follow-up (06jul2016): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (11jul2016): new information received from a contactable consumer included product data (frequency of thermacare menstrual and action taken with both products), and reaction data (outcome of events and clarification regarding hospitalization, the patient was not hospitalized due to the events).Followup (22may2020): new information received from product quality complaints (pqc) group included: additional product quality investigation results.Followup attempts completed.No further information expected.Amendment: this is a spontaneous report from a contactable consumer who reported same event to the same patient using different heat wraps.This case is for the use of thermacare menstrual.This is a follow-up report to notify us food and drug administration (fda) that mfr report number 1066015- 2016-00091 and mfr report number 1066015-2016- 00092 are duplicates.All subsequent follow-up information, for this patient and thermacare menstrual used, will be reported under mfr report number 1066015-2016-00091 (corresponding to company case number us-pfizer (b)(4).Mfr report number 1066015-2016-00092 is to be considered as deleted.In addition, a new pfizer individual safety report number corresponding to company case number (b)(4).Has been created for additional suspect thermacare lower back & hip for the same patient, and considered non-serious, non-reportable comment: based on the information provided, the events thermal burn and intentional device misuse as described in this case are considered a serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event product adhesion issue assessed as associated with the device.This case meets final 10- day eu and 30-day fda reportability.
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Manufacturer Narrative
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The root cause is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer alleges burn from wrap.A review of quality and manufacturing 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 and technical 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.Additional information received from pqc group on 22may2020 included additional investigation results.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.After a review of the atex smms menstrual material records for the batches of menstrual laminate used in this batch, the root cause of why the wraps would not adhere for use is inconclusive since review of records does not provide evidence to support defective product.The menstrual material 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.The product was within expiration date at the time the complaint was received; the product expired on 30sep2018.The product quality for the batch is not impacted by this complaint.An evaluation of the complaint history confirms that this is the first complaint for t he sub class adhesion/fastening defect received at the albany site requiring an evaluation for this batch.The complaints was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result was 11.This result was below the upper control limit (ucl) of 189.5 complaints.On the basis of this evaluation, a trend does not exist for this batch.Lot trend actions taken: a trend does not exist for this batch.Reasonably suggest device malfunction? yes.Severity of harm: s1.Site sample status: not received.
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Search Alerts/Recalls
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