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PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE JOINT PAIN; DISPOSABLE PACK, HOT
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| Lot Number X25964 |
| Device Problems
Leak/Splash (1354); Unsealed Device Packaging (1444); Defective Device (2588)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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| Event Date 01/01/2019 |
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Event Type
malfunction
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Event Description
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Two packages were not sealed properly/refer to the content of the wrap was leaked out [device leakage] , 2 packages were not sealed properly and did not work [device ineffective] ,.Case narrative: this is a spontaneous report from a contactable consumer.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), device lot number x25964, expiration date dec2021, upc number: (b)(4) from (b)(6) 2019 and ongoing at 1 patch per day for hip pain.The patient medical history was not reported.The patient's concomitant medications included ibuprofen (advil) from (b)(6) 2019 and ongoing.The reporter, at least weekly, purchased 3 to 4 boxes of thermacare, the x-shaped joint pain therapy, and she was pleased with the product, but she open the sealed box, and two packages were not sealed properly and did not work on (b)(6) 2019.The box was sealed and 2 packs were partially sealed, but the end wasn't sealed.The patient further confirmed 'the box was sealed and 2 packs were partially sealed, but the end wasn't sealed' refers to the content of the wrap was leaked out.The sample of the product was not available to be returned.The action taken in response to the event was continued.The patient was not admitted to hospital and did not receive any treatment.The outcome of the event was not resolved.Follow-up (b)(6) 2019): new information received from a contactable consumer included: patient age, suspect product details (including start date update to (b)(6) 2019, frequency updated to 1 patch per day), reaction data (including event onset date, the patient confirmed 'the box was sealed and 2 packs were partially sealed, but the end wasn't sealed' refer to the content of the wrap was leaked out, denied hospitalization and treatment, event outcome updated to not resolved), action taken updated to continued.This case is now updated to reportable malfunction medical device report.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the ¿content of the wrap was leaked out¿ was identified before use.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn., comment: based on the available information, the ¿content of the wrap was leaked out¿ was identified before use.No adverse event was associated with the use of the device.This is a single potential device malfunction which has a theoretical risk to cause skin burn.
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Event Description
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2 packages were not sealed properly and did not work [device ineffective].Case description: this is a spontaneous report from a contactable consumer.A 53-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), device lot number x25964, expiration date dec2021, upc number: 0573301724 from (b)(6) 2019 and ongoing at 1 patch per day for hip pain.The patient medical history was not reported.The patient's concomitant medications included ibuprofen (advil) from (b)(6) 2019 and ongoing.The reporter, at least weekly, purchased 3 to 4 boxes of thermacare, the x-shaped joint pain therapy, and she was pleased with the product, but she open the sealed box, and two packages were not sealed properly and did not work on (b)(6) 2019.The box was sealed and 2 packs were partially sealed, but the end wasn't sealed.In regards to whether "'the box was sealed and 2 packs were partially sealed, but the end wasn't sealed' refers to the content of the wrap was leaked out, the patient reported "confirm." the patient then later clarified that "the dark magnet looking parts of the wrap were fine and intact.The foil wrapper inside the cardboard box was what was not sealed.The box was sealed properly but the pouch was not and then the wraps were hard." a sample of the product was not available to be returned- they were thrown away.The action taken in response to the event with thermacare was continued.The patient was not admitted to hospital and did not receive any treatment.The outcome of the event was not resolved.Upon follow-up, product quality complaint provided the following investigation summary for complaints related to open pouches: the root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classess is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Lot-specific trend identified?: no.Sample status: not available.Confirmed compl.Sample defect?: no.Released batches meet criteria for pouch leaks at time of release.Follow-up (24may2019): new information received from a contactable consumer included: patient age, suspect product details (including start date update to (b)(6) 2019, frequency updated to 1 patch per day), reaction data (including event onset date, the patient confirmed 'the box was sealed and 2 packs were partially sealed, but the end wasn't sealed' refer to the content of the wrap was leaked out, denied hospitalization and treatment, event outcome updated to not resolved), action taken updated to continued.This case is now updated to reportable malfunction medical device report.Follow-up (29jul2019 and 20aug2019): new information received from product quality complaints includes: investigation results.Follow-up (23aug2019): new information from a contactable consumer (patient) includes: updated event description ("the dark magnet looking parts of the wrap were fine and intact.The foil wrapper inside the cardboard box was what was not sealed.The box was sealed properly but the pouch was not and then the wraps were hard.") and events ("device leakage" was removed).This complaint no longer meets the criteria of a reportable malfunction.Follow-up attempts are completed.No further information is expected.
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Manufacturer Narrative
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The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Reasonably suggest device malfunction?: yes.Lot- specific trend identified?: no.Sample status: not available.Confirmed compl.Sample defect?: no.Released batches meet criteria for pouch leaks at time of release.Based on the investigation results and the additional information provided by the complainant, this complaint no longer meets the criteria of a reportable malfunction.
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Manufacturer Narrative
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Root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Capa: the (site name) consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1 - no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.
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Event Description
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Event verbatim [preferred term].2 packages were not sealed properly and did not work [device ineffective], , narrative: this is a spontaneous report from a contactable consumer.A 53-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose joint pain), device lot number x25964, expiration date dec2021, upc number: 0573301724 from (b)(6)2019 and ongoing at 1 patch per day for hip pain.The patient medical history was not reported.The patient's concomitant medications included ibuprofen (advil) from (b)(6)2019 and ongoing.The reporter, at least weekly, purchased 3 to 4 boxes of thermacare, the x-shaped joint pain therapy, and she was pleased with the product, but she open the sealed box, and two packages were not sealed properly and did not work on (b)(6)2019.The box was sealed and 2 packs were partially sealed, but the end wasn't sealed.In regards to whether "'the box was sealed and 2 packs were partially sealed, but the end wasn't sealed' refers to the content of the wrap was leaked out, the patient reported "confirm." the patient then later clarified that "the dark magnet looking parts of the wrap were fine and intact.The foil wrapper inside the cardboard box was what was not sealed.The box was sealed properly but the pouch was not and then the wraps were hard." a sample of the product was not available to be returned- they were thrown away.The action taken in response to the event with thermacare was continued.The patient was not admitted to hospital and did not receive any treatment.The outcome of the event was not resolved.Upon follow-up, product quality complaint provided the following investigation summary for complaints related to open pouches: root cause of open pouches is equipment; specifically ultrasonic seal technology is not as forgiving in relation to the foil material as heat seal technology (external machine factors such as process variability and film material variability (wavy, wrinkles, thickness, surlyn conditions, etc.) affect the ability to keep the required film/product alignment and even pressure of the anvils across the sealing areas thus, compromising sealing integrity).In general, the leak defect rate has remained unchanged despite several reliability and engineering initiatives to improve the sealing performance.Capa: the (site name) consumer site will purchase and install three (3) new heat seal flow wrapper machines for b and m production lines.The existing bosch flow wrapper equipment used today employs ultrasonic sealing technology for both, the long and cross seals of the thermacare pouches.This technology has proven to be unreliable, difficult to maintain and not flexible enough to accommodate for material variances.The highest consumer complaint for the site is related to pouch sealing defects and the product never worked due to an open pouch.These complaints are directly related to failures during the sealing process.The new machines will utilize heat seal in the cross direction of the film/pouch to achieve a more consistent hermetic seal through the manufacturing runs with the added benefits of easier set up and operation.Complaint handling for open pouches: complaints received at the site in the global complaint database related to open pouch in the subclasses of (but not limited to) never worked, squeeze tube, did not last long enough and too cool will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to "open pouch" and the pouch sealing defect.No additional investigation will be required for these complaints based on the following: released batches meet criteria for pouch leaks at time of release.The severity of pouch leaks is s1 - no harm to customer.Complaints related to pouch seal have been thoroughly investigated and root cause is well understood.Leak rate for the current technology is about 2000 ppm.Capa is in-place to replace the ultrasonic sealers with heat seal technology.This document will be attached to the complaint record in the global database and closed with no further action taken.The root cause for never worked, too cool, did not last long enough and squeeze tube complaint sub classless is due to a pouch (primary packaging) that did not seal completely (open pouch).An open pouch will expose the wrap to air before the consumer gets it, causing it to be spent and not heating up.An open pouch is caused by equipment; specifically ultrasonic technology.The corrective action is to purchase and install three (3) new heat seal flow wrapper machines in both production lines.The severity of pouch leaks is s1 no harm to customer.Follow-up (24may2019): new information received from a contactable consumer included: patient age, suspect product details (including start date update to (b)(6)2019, frequency updated to 1 patch per day), reaction data (including event onset date, the patient confirmed 'the box was sealed and 2 packs were partially sealed, but the end wasn't sealed' refer to the content of the wrap was leaked out, denied hospitalization and treatment, event outcome updated to not resolved), action taken updated to continued.This case is now updated to reportable malfunction medical device report.Follow-up (29jul2019 and 20aug2019): new information received from product quality complaints includes: investigation results.Follow-up (23aug2019): new information from a contactable consumer (patient) includes: updated event description ("the dark magnet looking parts of the wrap were fine and intact.The foil wrapper inside the cardboard box was what was not sealed.The box was sealed properly but the pouch was not and then the wraps were hard.") and events ("device leakage" was removed).This complaint no longer meets the criteria of a reportable malfunction.Follow-up attempts are completed.No further information is expected.Follow-up (26aug2019): new information received from product quality complaints includes: investigation results.Amendment: this follow-up report is being submitted to notify us food and drug administration (fda) that mfr report number 1066015-2019-00179 and mfr report number 1066015-2019-00224 are duplicate.All subsequent follow-up information will be reported under mfr report number 1066015-2019-00179.Mfr report number 1066015-2019-00224 is to be considered as deleted.
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