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| Lot Number T81951 |
| Device Problem
Improper or Incorrect Procedure or Method (2017)
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| Patient Problem
Complaint, Ill-Defined (2331)
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Event Type
Injury
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Event Description
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Applies product directly to her skin and not over her clothes [device use error].Case narrative: the initial case was missing the following minimum criteria: no ae, product complaint only.Upon receipt of follow-up information on (01nov2019), this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.This (b)(6) year-old female consumer reported that she started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t81951, expiration date 31dec2020, upc: (b)(4), and lot number w92738; exp nov2021) from an unspecified date for back pain and soar back.Relevant medical history included hypertension, atrial fibrillation, anal cancer 28 years ago and the 28 radiations in groin area killed the nerves, neuropathy.Concomitant medication included: losartan started out at 50 mg and now 25 mg at bedtime for hypertension since at least 10 years; apixaban (eliquis) 5 mg twice a day since probably a year and half, for stroke prevention; flecainide at 50 mg twice a day since one year and half, for atrial fibrillation; gabapentin 300 mg three times a day since a year and half maybe, for neuropathy.Caller says she had purchased thermacare for back pain therapy.Caller says she used one from the box and it fit fine, but the second one she couldn't get it around her.Caller says she is so used to being able to pull the extension out so she can velcro it, but this one she was not able to use it, though it came from the same box she had used one from.Caller says she has been using this product for years, all the time when her lower back hurts.Caller says that this is the only one that she ever had an issue with where the second one didn't work to be worn with the extensions.Reporter stated she placed the wrap directly on her skin under her underpants but has never had a problem with burning or anything.Upon follow-up on (b)(6) 2019, it was reported that the patient's weight was (b)(6) lb, and height: 5'6' in.The problem was that she had used 1 unit in the back and it went around her.The second wrap did not have the extended pieces to go around her.Admission to hospital was involved for the event.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Additional information has been requested and will be provided as it becomes available.Follow-up (22nov2019): new information reported from a contactable consumer includes: lab data, seriousness of hospitalization, and product information (updated thermacare heatwrap indication, and added lot number and expiration).Follow up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported that "applies product directly to her skin and not over her clothes" requiring hospital admission is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.Comment: based on the available information, the patient reported that "applies product directly to her skin and not over her clothes" requiring hospital admission is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.
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Event Description
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Event verbatim [preferred term] applies product directly to her skin and not over her clothes [device use error].Case narrative:the initial case was missing the following minimum criteria: no ae, product complaint only.Upon receipt of follow-up information on (01nov2019), this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.This 77-year-old female patient (weight 177 lb, and height: 5'6 in) started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t81951, expiration date 31dec2020, upc 305733010020, and lot number w92738; exp nov2021) from an unspecified date for back pain and soar back.The patient medical history included hypertension, atrial fibrillation, anal cancer 28 years ago and the 28 radiations in groin area killed the nerves, and neuropathy.Concomitant medication included: losartan started out at 50 mg and now 25 mg at bedtime for hypertension since at least 10 years; apixaban (eliquis) 5 mg twice a day since probably a year and half, for stroke prevention; flecainide at 50 mg twice a day since one year and half, for atrial fibrillation; gabapentin 300 mg three times a day since a year and half maybe, for neuropathy.She had purchased thermacare for back pain therapy, and used one from the box and it fit fine, but the second one she couldn't get it around her.She was so used to being able to pull the extension out so she can velcro it.But this one she was not able to use it, though it came from the same box she had used one from, she couldn't get it on, there was no extension on it because and she can't get them around her belly it doesn't work.Additionally reported that "it is just that normally she can open it and there are two extensions that she can pull out but she couldn't connect them and she didn't want to mess with it and tear it off completely." the one she used before was fine, and was able to use the product while going to cut the grass and take out leaves because "she jerry rigged it since it wouldn't connect in the front".The patient had been using this product for years, all the time when her lower back hurt.This was the only one that she ever had an issue with where the second one didn't work to be worn with the extensions.She placed the wrap directly on her skin under her underpants but has never had a problem with burning or anything.The problem was that she had used 1 unit in the back and it went around her.The second wrap did not have the extended pieces to go around her.Admission to hospital was involved for the event.Sample of the product was not available to be returned as she threw it out as she used it by putting it in her underpants to get back out on the tractor, also reported as was available (discrepant information reported).Product box contained 2 wraps and only one was affected.Number as being after the lot number: 01/22.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Following information provided by product quality complaint group: complaint class: external cause investigation.Complaint sub-class: adverse event/negligible-minor.Packaging was sealed and intact.Sterile product: no.Reasonably suggest device malfunction: yes.Severity of harm: s1.Capa previously identified: qa review & rationale: see below, conclusion.Summary of investigation: see below, conclusion.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient experienced misfit with device use even with use of extensions.No serious harm or injury was reported.Reserve sample evaluation required: no.Lot-specific trend identified: no.Sample status: not available.Site sample status: not received.Follow-up (22nov2019): new information reported from a contactable consumer includes: lab data, seriousness of hospitalization, and product information (updated thermacare heatwrap indication, and added lot number and expiration).Follow up attempts are completed.No further information is expected.Follow up (07nov2019): new information from product quality complaint group included: complaint class/subclass, severity of harm, sample availability, summary of investigation, conclusion and other investigation findings, and information about the one she used before and activities.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported that "applies product directly to her skin and not over her clothes" requiring hospital admission is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the available information, the patient reported that "applies product directly to her skin and not over her clothes" requiring hospital admission is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Complaint class: external cause investigation.Complaint sub-class: adverse event/negligible-minor.Packaging was sealed and intact.Sterile product: no.Reasonably suggest device malfunction: yes.Severity of harm: s1.Capa previously identified: qa review & rationale: see below, conclusion.Summary of investigation: see below, conclusion.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient experienced misfit with device use even with use of extensions.No serious harm or injury was reported.Reserve sample evaluation required: no.Lot-specific trend identified: no.Sample status: not available.Site sample status: not received.
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Event Description
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Applies product directly to her skin and not over her clothes [device use error].Case narrative: the initial case was missing the following minimum criteria: no ae, product complaint only.Upon receipt of follow-up information on (01nov2019), this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.This 77-year-old female patient (weight 177 lb, and height: 5'6 in) started to use thermacare heatwrap (thermacare lower back & hip) (device lot number t81951, expiration date 31dec2020, upc 305733010020) from an unspecified date for back pain and soar back.The patient medical history included hypertension, atrial fibrillation, anal cancer 28 years ago (from 1991) and the 28 radiations in groin area killed the nerves, and neuropathy.Concomitant medication included: losartan started out at 50 mg and now 25 mg at bedtime for hypertension since at least 10 years; apixaban (eliquis) 5 mg twice a day since probably a year and half, for stroke prevention; flecainide at 50 mg twice a day since one year and half, for atrial fibrillation; gabapentin 300 mg three times a day since a year and half maybe, for neuropathy.She had purchased thermacare for back pain therapy, and used one from the box and it fit fine, but the second one she couldn't get it around her.She was so used to being able to pull the extension out so she can velcro it.But this one she was not able to use it, though it came from the same box she had used one from, she couldn't get it on, there was no extension on it because and she can't get them around her belly it doesn't work.Additionally reported that "it is just that normally she can open it and there are two extensions that she can pull out but she couldn't connect them and she didn't want to mess with it and tear it off completely." the one she used before was fine, and was able to use the product while going to cut the grass and take out leaves because "she jerry rigged it since it wouldn't connect in the front".The patient had been using this product for years, all the time when her lower back hurt.This was the only one that she ever had an issue with where the second one didn't work to be worn with the extensions.She placed the wrap directly on her skin under her underpants but has never had a problem with burning or anything.The problem was that she had used 1 unit in the back and it went around her.The second wrap did not have the extended pieces to go around her.Admission to hospital was involved for the event.Sample of the product was not available to be returned as she threw it out as she used it by putting it in her underpants to get back out on the tractor, also reported as was available (discrepant information reported).Product box contained 2 wraps and only one was affected.Number as being after the lot number: 01/22.Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report.Following information provided by product quality complaint group: complaint class: external cause investigation.Complaint sub-class: adverse event/negligible-minor.Packaging was sealed and intact.Sterile product: no.Reasonably suggest device malfunction: yes.Severity of harm: s1.Capa previously identified: qa review & rationale: see below, conclusion.Summary of investigation: see below, conclusion.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient experienced misfit with device use even with use of extensions.No serious harm or injury was reported.Reserve sample evaluation required: no.Lot-specific trend identified: no.Sample status: not available.Site sample status: not received.Complaint handling for non-defect subclass: complaints received at the site in the global complaint database related to non-defect will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to a non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.Follow-up (22nov2019): new information reported from a contactable consumer includes: lab data, seriousness of hospitalization, and product information (updated thermacare heatwrap indication, and added lot number and expiration).Follow up attempts are completed.No further information is expected.Follow up (07nov2019): new information from product quality complaint group included: complaint class/subclass, severity of harm, sample availability, summary of investigation, conclusion and other investigation findings, and information about the one she used before and activities.Follow-up attempts are completed.No further information is expected.Follow-up (09jan2020 and 15jan2020): new information received from product quality complaint group and consumer included: investigation results and that lot # w92738 is for thermacare neck/shoulder/wrist.Follow-up attempts are completed.No further information is expected.Company clinical evaluation comment: based on the available information, the patient reported that "applies product directly to her skin and not over her clothes" requiring hospital admission is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: based on the available information, the patient reported that "applies product directly to her skin and not over her clothes" requiring hospital admission is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event is medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.In the case narrative there is evidence of device use error which most likely contributed to this incident.No remedial action/corrective action/field safety corrective action is suggested at this time.
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Manufacturer Narrative
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Complaint class: external cause investigation.Complaint sub-class: adverse event/negligible-minor.Packaging was sealed and intact.Sterile product: no.Reasonably suggest device malfunction: yes.Severity of harm: s1.Capa previously identified: qa review & rationale: see below, conclusion.Summary of investigation: see below, conclusion.Final confirmation status: not confirmed.Product quality impact: no.Market / clinical impact: no.Stability impact: no.Conclusion: a summary investigation is being performed as providing the batch record information is the manufacturing site's requirement.Based on the complaint narrative, the patient experienced misfit with device use even with use of extensions.No serious harm or injury was reported.Reserve sample evaluation required: no.Lot-specific trend identified: no.Sample status: not available.Site sample status: not received.Complaint handling for non-defect subclass: complaints received at the site in the global complaint database related to non-defect will not be investigated in qts.These complaints will be evaluated in the global complaint database to ensure they are due to a non-defect issue.No additional investigation will be required for these complaints based on the following: released batches met specification criteria at the time of release.There is no severity assigned to a non-defect.This document will be attached to the complaint record in the global database and closed with no further action taken.
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Search Alerts/Recalls
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