|
|
| Lot Number W87447, W92739, T26693, T26691 |
| Device Problems
Fluid/Blood Leak (1250); Nonstandard Device (1420); Overheating of Device (1437); Material Puncture/Hole (1504)
|
| Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
| Event Date 08/01/2018 |
|
Event Type
malfunction
|
|
Manufacturer Narrative
|
|
Investigation results for lot number w92739.The root cause category is non-assignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.W87447 expiration date: 01mar2021.The root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required.No final confirmation status: not confirmed.
|
| |
|
Event Description
|
|
It opened in my underwear and spilled contents down my pants and in the toilet [device leakage], wraps had holes and stayed hot for a very long time/ found the holes prior to applying [intentional device misuse], wraps had holes and stayed hot for a very long time/ found the holes prior to applying/create excessive heat even after being opened for 36hrs [device issue].Case narrative:the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 07jan2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare menstrual) (device lot number: w87447, expiration date mar2021; device lot number: w92739, expiration date jun2021, device lot numbers t26693 and t26691 (no expiration date provided) used 1 heat wrap per day as needed from an unspecified date for relief of menstrual cramps.Product has been used for over 5 years and have never had a problem until several months ago.The patients medical history was not reported.No concomitant medications.On (b)(6) 2018, the patient reported the wraps had holes and stayed hot for a very long time.She had them opened for over 24 hours, and they sat in the cold car and were still hot.There were six boxes affected, with two different lot numbers.On (b)(6) 2018 the patient experienced leakage with lot # t26693 & t26691, thermacare heat wrap opened up and the contents spilled in underwear, toilet and down pants.It was discovered immediately and was able to promptly shower off the contents so no burns resulted.8 different boxes from these lot numbers were affected.No hospitalization was involved.Action taken with the suspect product was permanently withdrawn on (b)(6) 2018.Clinical outcome of the event accidental exposure was recovered and the clinical outcome of remaining event was unknown.Consumer no longer has the product as it was returned to the supermarket and was refunded.Additional information received from product quality complaint (pqc) group included investigation results for lot number w92739.The root cause category is non-assignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary: w87447 expiration date: 01mar2021.The root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required.No final confirmation status: not confirmed.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: the above referenced lot numbers t26693 and t26691 were recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.Comment: the above referenced lot numbers t26693 and t26691 were recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
|
| |
|
Manufacturer Narrative
|
|
Investigation results for lot number w92739: the root cause category is nonassignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is nonassignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required no final confirmation status: not confirmed.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within ex.
|
| |
|
Event Description
|
|
Wraps had holes and stayed hot for a very long time/ found the holes prior to applying [intentional device misuse] it opened in my underwear and spilled contents down my pants and in the toilet/the cells seemed to be falling out of the wrap and it looked more as granules [device leakage] wraps had holes and stayed hot for a very long time/ found the holes prior to applying/create excessive heat even after being opened for 36hrs [device issue] case description: the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 07jan2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A 28-year-old female patient started to use thermacare heatwrap (thermthe top adhesive was gone/it wasn't acare menstrual), device lot number: w87447, expiration date 01mar2021; device lot number: w92739, expiration date jun2021; device lot number: t26693, expiration date: aug2020; device lot number: t26691 (no expiration date provided) used 1 heat wrap per day as needed from aug2018 for relief of menstrual cramps.Product has been used for over 5 years and has never had a problem until several months ago.The patient's medical history was not reported.No concomitant medications.In aug2018, the patient reported the wraps had holes and stayed hot for a very long time and created excessive heat even after being opened for 36hrs.She had them opened for over 24 hours, and they sat in the cold car and were still hot.There were six boxes affected, with two different lot numbers.In aug2018 the patient experienced leakage with lot # t26693 & t26691, thermacare heat wrap opened up and the contents spilled in underwear, toilet and down pants.The cells seemed to be falling out of the wrap and it looked more as granules.It was discovered immediately and was able to promptly shower off the contents so no burns resulted.8 different boxes from these lot numbers were affected.The patient also found the holes prior to applying in nov2018.No hospitalization was involved.And no treatment was received.Action taken with the suspect product was permanently withdrawn in nov2018.Clinical outcome of the events was resolved on unknown date.Consumer no longer had the product as it was returned to the supermarket and was refunded.Additional information received from product quality complaint (pqc) group included investigation results for lot number w92739: the root cause category is non-assignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required no final confirmation status: not confirmed.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr 2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr 2379610.Follow-up (18jan2019): new information received from product quality complaint group includes investigation results.Follow-up (31may2019): follow-up attempts are completed.No further information is expected.Follow-up (28may2019): new information received from a contactable consumer included: patient age, event onset date, outcome, and no treatment received.Amendment: this follow-up report is being submitted to amend previously reported information: in eu/ca device section, ticked "near incident" and "final report" checkbox.Company clinical evaluation comment: the above referenced lot numbers t26693 and t26691 were recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
|
| |
|
Manufacturer Narrative
|
|
Investigation summary for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation (b)(4) menstrual & muscle joint us cells damaged/leaking was conducted for the same subclass.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).
|
| |
|
Event Description
|
|
Wraps had holes and stayed hot for a very long time/ found the holes prior to applying [intentional device misuse].It opened in my underwear and spilled contents down my pants and in the toilet/the cells seemed to be falling out of the wrap and it looked more as granules [device leakage].Wraps had holes and stayed hot for a very long time/ found the holes prior to applying/create excessive heat even after being opened for 36hrs [device issue].Case description: the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 07jan2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A 28 years old female patient started to use thermacare heatwrap (thermthe top adhesive was gone/it wasn't acare menstrual), device lot number: w87447, expiration date 01mar2021; device lot number: w92739, expiration date jun2021; device lot number: t26693, expiration date: aug2020; device lot number: t26691 (no expiration date provided) used 1 heat wrap per day as needed from (b)(6) 2018 for relief of menstrual cramps.Product has been used for over 5 years and have never had a problem until several months ago.The patient's medical history was not reported.No concomitant medications.On (b)(6) 2018, the patient reported the wraps had holes and stayed hot for a very long time and create excessive heat even after being opened for 36hrs.She had them opened for over 24 hours, and they sat in the cold car and were still hot.There were six boxes affected, with two different lot numbers.On (b)(6) 2018 the patient experienced leakage with lot # t26693 & t26691, thermacare heat wrap opened up and the contents spilled in underwear, toilet and down pants.The cells seemed to be falling out of the wrap and it looked more as granules.It was discovered immediately and was able to promptly shower off the contents so no burns resulted.8 different boxes from these lot numbers were affected.The patient also found the holes prior to applying on (b)(6) 2018.No hospitalization was involved.And no treatment was received.Action taken with the suspect product was permanently withdrawn on (b)(6) 2018.Clinical outcome of the event "i can no longer trust they will be safe and made effectively" was unknown and the clinical outcome of remaining event was recovered.Consumer no longer has the product as it was returned to the supermarket and was refunded.Additional information received from product quality complaint (pqc) group included investigation results for lot number w92739: the root cause category is non-assignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required no final confirmation status: not confirmed.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation (b)(4) menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).Follow-up (18jan2019): new information received from product quality complaint group includes investigation results.Follow-up (31may2019): follow-up attempts are completed.No further information is expected.Follow-up (28may2019): new information received from a contactable consumer included: patient age, event onset date, outcome, and no treatment received.Company clinical evaluation comment: the above referenced lot numbers t26693 and t26691 were recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
|
| |
|
Manufacturer Narrative
|
|
Investigation summary for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr 2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same subclass.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).
|
| |
|
Event Description
|
|
It opened in my underwear and spilled contents down my pants and in the toilet [device leakage].Wraps had holes and stayed hot for a very long time/ found the holes prior to applying [intentional device misuse].Wraps had holes and stayed hot for a very long time/ found the holes prior to applying/create excessive heat even after being opened for 36hrs [device issue].Case description: the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 07jan2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to use thermacare heatwrap (thermacare menstrual), device lot number: w87447, expiration date 01mar2021; device lot number: w92739, expiration date jun2021; device lot number: t26693, expiration date: aug2020; device lot number: t26691 (no expiration date provided) used 1 heat wrap per day as needed from an unspecified date for relief of menstrual cramps.Product has been used for over 5 years and have never had a problem until several months ago.The patient's medical history was not reported.No concomitant medications.On nov2018, the patient reported the wraps had holes and stayed hot for a very long time.She had them opened for over 24 hours, and they sat in the cold car and were still hot.There were six boxes affected, with two different lot numbers.On sep2018 the patient experienced leakage with lot # t26693 & t26691, thermacare heat wrap opened up and the contents spilled in underwear, toilet and down pants.It was discovered immediately and was able to promptly shower off the contents so no burns resulted.8 different boxes from these lot numbers were affected.No hospitalization was involved.Action taken with the suspect product was permanently withdrawn on nov2018.Clinical outcome of the event accidental exposure was recovered and the clinical outcome of remaining event was unknown.Consumer no longer has the product as it was returned to the supermarket and was refunded.Additional information received from product quality complaint (pqc) group included investigation results for lot number w92739: the root cause category is non-assignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required no final confirmation status: not confirmed.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr 2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr 2379610.Follow-up (18jan2019): new information received from product quality complaint group includes investigation results.Company clinical evaluation comment: the above referenced lot numbers t26693 and t26691 were recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
|
| |
|
Manufacturer Narrative
|
|
Investigation results for lot number w92739: the root cause category is nonassignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is nonassignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required no final confirmation status: not confirmed.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within ex.
|
| |
|
Event Description
|
|
Wraps had holes and stayed hot for a very long time/ found the holes prior to applying [intentional device misuse].It opened in my underwear and spilled contents down my pants and in the toilet/the cells seemed to be falling out of the wrap and it looked more as granules [device leakage].Wraps had holes and stayed hot for a very long time/ found the holes prior to applying/create excessive heat even after being opened for 36hrs [device issue].Case description: the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 07jan2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A 28-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: w87447, expiration date 01mar2021; device lot number: w92739, expiration date jun2021; device lot number: t26693, expiration date: aug2020; device lot number: t26691 (no expiration date provided)) used 1 heatwrap per day as needed from (b)(6) 2018 for relief of menstrual cramps.Product has been used for over 5 years and has never had a problem until several months ago.The patient's medical history was not reported.No concomitant medications.In (b)(6) 2018, the patient reported the wraps had holes and stayed hot for a very long time and created excessive heat even after being opened for 36hrs.She had them opened for over 24 hours, and they sat in the cold car and were still hot.There were six boxes affected, with two different lot numbers.In (b)(6) 2018 the patient experienced leakage with lot # t26693 & t26691, thermacare heat wrap opened up and the contents spilled in underwear, toilet and down pants.The cells seemed to be falling out of the wrap and it looked more as granules.It was discovered immediately and was able to promptly shower off the contents so no burns resulted.8 different boxes from these lot numbers were affected.The patient also found the holes prior to applying in nov2018.No hospitalization was involved.And no treatment was received.Action taken with the suspect product was permanently withdrawn in (b)(6) 2018.Clinical outcome of the events was resolved on unknown date.Consumer no longer had the product as it was returned to the supermarket and was refunded.Additional information received from product quality complaint (pqc) group included investigation results for lot number w92739: the root cause category is non-assignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required no final confirmation status: not confirmed.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr (b)(4).Follow-up (18jan2019): new information received from product quality complaint group includes investigation results.Follow-up (31may2019): follow-up attempts are completed.No further information is expected.Follow-up (28may2019): new information received from a contactable consumer included: patient age, event onset date, outcome, and no treatment received.Amendment: this follow-up report is being submitted to amend previously reported information: in eu/ca device section, ticked "near incident" and "final report" checkbox.Follow-up (15jul2019): new information received from a contactable consumer includes: the patient denied further correspondence.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: the above referenced lot numbers t26693 and t26691 were recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
|
| |
|
Event Description
|
|
Wraps had holes and stayed hot for a very long time/ found the holes prior to applying [intentional device misuse] it opened in my underwear and spilled contents down my pants and in the toilet/the cells seemed to be falling out of the wrap and it looked more as granules [device leakage] wraps had holes and stayed hot for a very long time/ found the holes prior to applying/create excessive heat even after being opened for 36hrs [device issue] case description: the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 07jan2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A 28-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: w87447, expiration date 01mar2021; device lot number: w92739, expiration date jun2021; device lot number: t26693, expiration date: aug2020; device lot number: t26691 (no expiration date provided)) used 1 heatwrap per day as needed from (b)(6)2018 for relief of menstrual cramps.Product has been used for over 5 years and has never had a problem until several months ago.The patient's medical history was not reported.No concomitant medications.In (b)(6)2018, the patient reported the wraps had holes and stayed hot for a very long time and created excessive heat even after being opened for 36hrs.She had them opened for over 24 hours, and they sat in the cold car and were still hot.There were six boxes affected, with two different lot numbers.In (b)(6)2018 the patient experienced leakage with lot # t26693 & t26691, thermacare heat wrap opened up and the contents spilled in underwear, toilet and down pants.The cells seemed to be falling out of the wrap and it looked more as granules.It was discovered immediately and was able to promptly shower off the contents so no burns resulted.8 different boxes from these lot numbers were affected.The patient also found the holes prior to applying in (b)(6)2018.No hospitalization was involved.And no treatment was received.Action taken with the suspect product was permanently withdrawn in (b)(6)2018.Clinical outcome of the events was resolved on unknown date.Consumer no longer had the product as it was returned to the supermarket and was refunded.Additional information received from product quality complaint (pqc) group included investigation results for lot number w92739: the root cause category is non-assignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required no final confirmation status: not confirmed.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr 2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr 2379610.As of (b)(6)2019, for lot w87447, w92739, t26693, t26691: reasonably suggest device malfunction: yes, severity of harm: s3.Follow-up (18jan2019): new information received from product quality complaint group includes investigation results.Follow-up (31may2019): follow-up attempts are completed.No further information is expected.Follow-up (28may2019): new information received from a contactable consumer included: patient age, event onset date, outcome, and no treatment received.Amendment: this follow-up report is being submitted to amend previously reported information: in eu/ca device section, ticked "near incident" and "final report" checkbox.Follow-up (15jul2019): new information received from a contactable consumer includes: the patient denied further correspondence.Follow-up attempts are completed.No further information is expected.Follow-up (23aug2019): new information received from a product quality complaint group included: severity ranking.Company clinical evaluation comment: the above referenced lot numbers t26693 and t26691 were recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
|
| |
|
Manufacturer Narrative
|
|
Investigation results for lot number w92739: the root cause category is nonassignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is nonassignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required no final confirmation status: not confirmed.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within ex.
|
| |
|
Manufacturer Narrative
|
|
Investigation results for lot number w92739: the root cause category is non-assignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Process related: no, complaint confirmed: no, design related: no, notify safety: no, conclusion and approvals: additional approval required no final confirmation status: not confirmed.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr 2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr 2379610.For lot w87447, w92739, t26693, t26691: reasonably suggest device malfunction: yes, severity of harm: s3.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] wraps had holes and stayed hot for a very long time/ found the holes prior to applying [intentional device misuse], it opened in my underwear and spilled contents down my pants and in the toilet/the cells seemed to be falling out of the wrap and it looked more as granules [device leakage], wraps had holes and stayed hot for a very long time/ found the holes prior to applying/create excessive heat even after being opened for 36hrs [device issue], , narrative: the initial case was missing the following minimum criteria: no adverse event.Upon receipt of follow-up information on 07jan2019, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A 28-year-old female patient started to use thermacare heatwrap (thermacare menstrual) (device lot number: w87447, expiration date 01mar2021; device lot number: w92739, expiration date jun2021; device lot number: t26693, expiration date: aug2020; device lot number: t26691 (no expiration date provided)) used 1 heatwrap per day as needed from aug2018 for relief of menstrual cramps.Product has been used for over 5 years and has never had a problem until several months ago.The patient's medical history was not reported.No concomitant medications.In aug2018, the patient reported the wraps had holes and stayed hot for a very long time and created excessive heat even after being opened for 36hrs.She had them opened for over 24 hours, and they sat in the cold car and were still hot.There were six boxes affected, with two different lot numbers.In aug2018 the patient experienced leakage with lot # t26693 & t26691, thermacare heat wrap opened up and the contents spilled in underwear, toilet and down pants.The cells seemed to be falling out of the wrap and it looked more as granules.It was discovered immediately and was able to promptly shower off the contents so no burns resulted.8 different boxes from these lot numbers were affected.The patient also found the holes prior to applying in nov2018.No hospitalization was involved and no treatment was received.Action taken with the suspect product was permanently withdrawn in nov2018.Clinical outcome of the events was resolved on unknown date.Consumer no longer had the product as it was returned to the supermarket and was refunded.Additional information received from product quality complaint (pqc) group included investigation results for lot number w92739: the root cause category is non-assignable (complaint not confirmed).The sample is not available for evaluation by the site, the complaint cannot be confirmed.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.Investigation summary for lot number: w87447 expiration date: 01mar2021: the root cause category is non-assignable (complaint not confirmed).The sample has not been received at the site for evaluation; the complaint cannot be confirmed.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.Investigation summary on 18jan2019 for lot number: t26693, expiration date: aug2020: the root cause category is non assignable (complaint not confirmed).The consumer returned sample is not available for evaluation, without the defective wrap for evaluation the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr 2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr 2379610.As of 23aug2019, for lot w87447, w92739, t26693, t26691: reasonably suggest device malfunction: yes, severity of harm: s3.Follow-up (18jan2019): new information received from product quality complaint group includes investigation results.Follow-up (31may2019): follow-up attempts are completed.No further information is expected.Follow-up (28may2019): new information received from a contactable consumer included: patient age, event onset date, outcome, and no treatment received.Amendment: this follow-up report is being submitted to amend previously reported information: in eu/ca device section, ticked "near incident" and "final report" checkbox.Follow-up (15jul2019): new information received from a contactable consumer includes: the patient denied further correspondence.Follow-up (23aug2019): new information received from a product quality complaint group included: severity ranking.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number and mfr report number 1066015-2019-00028 are duplicate.All subsequent follow-up information will be reported under mfr report number.Mfr report number 1066015-2019-00028 is to be considered as deleted.Follow-up attempts are completed.No further information is expected., comment: the above referenced lot numbers t26693 and t26691 were recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
|
| |
|
Search Alerts/Recalls
|
|
|
