MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

Lot Number 7207SB; S97479

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994); Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)

Event Date 08/01/2019

Event Type Injury

Event Description

Manufacturer Narrative

Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08aug2016 through 08aug2019 / manufacturing site: pfizer albany/ complaint class: external cause investigation / complaint sub class: adverse event / serious / unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 669 complaints for lbh products during this time period for the class / subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event / serious / unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches: s00639, s23902, s97473 and w37940 from apr2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat / cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.This is also observed in a review of the 24 month trend chart for this subclass.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo (b)(4) and are not valid adverse events.Based on thi.

Event Description

Blisters on his / her back from the patch / pain / open blisters / burning sensitivity / sensitive and highly irritated / bumps [burns second degree].Case narrative: this is a spontaneous report from a contactable consumer (patient).A 34-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) reported as device lot#: 7207sb, with master lot#: s97479 (both confirmed as not valid), expiry, 31mar2020, on 01aug2019, at 1 patch, for sciatica pain.Product number: 4099208 and upc: 30573174036.The patient's medical history included ongoing sciatica.She has ongoing chronic pain and seeks any relief that is not in pill form.Concomitant medications were none.The patient purchased the product during on (b)(6) 2019 to treat lower back and hip area.Her doctor recommended she use the product for sciatica.She applied it to the lower back to relieve sciatic pain on (b)(6) 2019.She used one patch for less than 4 hours and had blisters on her back from the patch.It blistered up her sciatic area on (b)(6) 2019.The patent was very upset that his/her money was wasted on a product that caused more injury to her back than it helped.The patient had photos of the blistering and was seeking compensation for missing work and for her suffering.Photos were provided by the reporter on (b)(6) 2019.With regards to "the product causing more injury to her back," she described that there was more sensitivity around blistered area and sciatica area.The area under corners and some of the middle blisters are very painful.She could not wear a shirt.The area also became sensitive and highly irritated.She described her symptoms after using thermacare as: open blisters / blisters and open skin, burning sensitivity, sensitivity, irritation and bumps, pain, and "fear"; she was unable to wear a top for a day and a half and unable to go to work.She missed a day of work because she couldn't wear a shirt.There was no hospital admission for the events.She was not under the care of a medical doctor and did not receive treatment for the events.The patient was still suffering from the blistering on (b)(6) 2019 and wanted to get a check to cover costs from the pain.She later reported it took several weeks for the blisters to heal; blisters were still healing at this point (as of report on (b)(6) 2019).As of on (b)(6) 2019, the patient reported her back was still very sensitive she was assuming its something she just had to live with.She used patch for less than 4 hours and upon removal there were limps blisters and all if the standard the patch became sensitive and was still tender.The blisters lasted 1 month.The bumps lasted 6 weeks.Sensitivity was still a problem, it continued.The patient classified her skin tone as medium (neither light nor dark).The patient did not have abnormal skin conditions.She purchased the red box.There was not product remaining.She did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She confirmed no heating methods were used on product since it was self-heating; it was not heated in a microwave prior to usage and was not re-heated at all during usage.She used the product for 1 day, for less than 4 hours in a matter of 24 hours.She did not leave the product on while she was sleeping.She placed the patch on her back directly/ directly to skin.There was no skin damage prior to usage.The area had not bruised or swelled 48 hours prior to usage of thermacare.She checked skin frequently while using the product, every hour.She read the usage instructions on thermacare before she used the product.She did not engage in exercise while using the product.She did not detect irritation, redness, or burning until she removed the patch completely.The patch was worn under clothing, but only a single loosely fitting shirt for comfort.Thermacare was not used with pain rubs, medical lotions, creams or ointments.The patient did not have diabetes, poor circulation or heart disease, rheumatoid arthritis, and was not pregnant.The patient no longer had the thermacare carton.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on 01aug2019.The event outcome was recovering.Product quality complaints provided the following severity of harm rating: s3.Product investigation results were as follows: exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08aug2016 through 08aug2019 / manufacturing site: pfizer albany / complaint class: external cause investigation / complaint sub class: adverse event / serious / unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 669 complaints for lbh products during this time period for the class / subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event / serious / unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches: s00639, s23902, s97473 and w37940 from apr2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat / cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.This is also observed in a review of the 24 month trend chart for this subclass.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo (b)(4) and are not valid adverse events.Based on this citi customizable search for the subclasses of adverse event/serious / unknown, adverse event safety request for investigation and adverse negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event / serious / unknown, adverse event safety request for investigation and adverse negligible-minor for lbh product.This investigation was conducted for an unknown lot number of lower back and hip (lbh) product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious / unknown.The 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.Reasonably suggest device malfunction was yes ; severity of harm was s3; site sample status was not received.Follow-up (05aug2019): new information received from the same contactable consumer included: medical history, product expiration date, and event details and outcome.Follow-up (08aug2019 and 09aug2019): new information received from a product quality complaint group includes: severity of harm (s3).Follow-up (16sep2019): new information from a contactable consumer includes: product information (lot no / expiry/ upc, start date, indication) and patient information (date of birth, age, height, weight).Follow- up (16sep2019 and 24sep2019): new information from a contactable consumer received via glaxosmithkline, license party for thermacare, includes: patient information (gender), patient history (chronic pain), product information, additional event information (updated event description and event selection to "burn blister"), photos, hospitalization information (none), treatment information (none).This report is upgraded to a serious, reportable medical device report based on additional event description and photos received on 16sep2019.Follow-up (16sep2019): this case is being submitted to notify that the follow-up information previously considered to have been initially received by the company on 24sep2019 was instead received on 16sep2019.Follow-up(28oct2019): new information from a contactable consumer includes: product usage information and event details.Follow-up (29aug2019): new information received from a product quality complaint group includes product investigation results.Company clinical evaluation comment: based on the information provided, the event of "burn blister" as described 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 information provided, the event of "burn blister" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and / or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No further investigations or actions is suggested at this time.

Manufacturer Narrative

Exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08aug2016 through 08aug2019/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 669 complaints for lbh products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.This is also observed in a review of the 24 month trend chart for this subclass.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.

Event Description

Event verbatim [preferred term] blisters on his/her back from the patch/ pain/open blisters/ burning sensitivity/ sensitive and highly irritated/ bumps [burns second degree].Case narrative:this is a spontaneous report from a contactable consumer (patient).A 34-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) reported as device lot # 7207sb, with master lot # s97479 (both confirmed as not valid), expiry, 31mar2020, on (b)(6)2019, at 1 patch, for sciatica pain.Product number 4099208 and upc 30573174036.The patient's medical history included ongoing sciatica.She has ongoing chronic pain and seeks any relief that is not in pill form.Concomitant medications were none.The patient purchased the product during (b)(6)2019 to treat lower back and hip area.Her doctor recommended she use the product for sciatica.She applied it to the lower back to relieve sciatic pain on (b)(6)2019.She used one patch for less than 4 hours and had blisters on her back from the patch.It blistered up her sciatic area on (b)(6)2019.The patent was very upset that his/her money was wasted on a product that caused more injury to her back than it helped.The patient had photos of the blistering and was seeking compensation for missing work and for her suffering.Photos were provided by the reporter on (b)(6)2019.With regards to "the product causing more injury to her back," she described that there was more sensitivity around blistered area and sciatica area.The area under corners and some of the middle blisters are very painful.She could not wear a shirt.The area also became sensitive and highly irritated.She described her symptoms after using thermacare as: open blisters/ blisters and open skin, burning sensitivity, sensitivity, irritation and bumps, pain, and "fear"; she was unable to wear a top for a day and a half and unable to go to work.She missed a day of work because she couldn't wear a shirt.There was no hospital admission for the events.She was not under the care of a medical doctor and did not receive treatment for the events.The patient was still suffering from the blistering on (b)(6)2019 and wanted to get a check to cover costs from the pain.She later reported it took several weeks for the blisters to heal; blisters were still healing at this point (as of report on (b)(6)2019).As of (b)(6)2019, the patient reported her back was still very sensitive she was assuming its something she just had to line with.She used patch for less than 4 hours and upon removal there were limps blisters and all if the standard the patch became sensitive and was still tender.The blisters lasted 1 month.The bumps lasted 6 weeks.Sensitivity was still a problem, it continued.The patient classified her skin tone as medium (neither light nor dark).The patient did not have abnormal skin conditions.She purchased the red box.There was not product remaining.She did not previously use other heat products for pain relief (electric heating pad, hot water bottle, microwave gel pack).She confirmed no heating methods were used on product since it was self-heating; it was not heated in a microwave prior to usage and was not re-heated at all during usage.She used the product for 1 day, for less than 4 hours in a matter of 24 hours.She did not leave the product on while she was sleeping.She placed the patch on her back directly/ directly to skin.There was no skin damage prior to usage.The area had not bruised or swelled 48 hours prior to usage of thermacare.She checked skin frequently while using the product, every hour.She read the usage instructions on thermacare before she used the product.She did not engage in exercise while using the product.She did not detect irritation, redness, or burning until she removed the patch completely.The patch was worn under clothing, but only a single loosely fitting shirt for comfort.Thermacare was not used with pain rubs, medical lotions, creams or ointments.The patient did not have diabetes, poor circulation or heart disease, rheumatoid arthritis, and was not pregnant.The patient no longer had the thermacare carton.The action taken in response to the event for thermacare heatwrap was permanently withdrawn on (b)(6)2019.The event outcome was recovering.Product quality complaints provided the following severity of harm rating: s3.Product investigation results were as follows: exped trend assmt.& rationale: an evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following complaint intake, triage, and investigation (citi) customizable search was performed: scope: site notification date: 08aug2016 through 08aug2019/manufacturing site: pfizer albany/complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The citi customizable search returned a total of 669 complaints for lbh products during this time period for the class/subclass.None were confirmed to have a manufacturing process root cause for a complaint of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor.The subclasses show an increase in nov2018 thru jan2019.This is a seasonality change in combination with a change in safety's procedure that has incorporated requesting site investigations for complaints with or without batch number; thus representing a shift in the expected baseline.The data shows a trend emerging for the subclass in april and may2019.Complaints increased due to consumers reporting adverse events after being notified of a product recall.Consumers referenced the too hot recall of batches s00639, s23902, s97473 and w37940 from apr2019.A review of the 36 month trend chart for batches with unknown batch numbers shows a spike in april and may2019.The majority of the complaints by description have a severity ranking of s1-too cool, heat/cold did not last long enough, never worked, squeeze tube pouch damage defect per prt-38832 hazard analysis, thermacare heat wrap product: 8 and 12hr.This is also observed in a review of the 24 month trend chart for this subclass.These complaints are classified as an open-pouch.All open pouch complaints are investigated per investigation memo cd-66388 and are not valid adverse events.Based on this citi customizable search for the subclasses of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown, adverse event safety request for investigation and adverse negligible-minor for lbh product.This investigation was conducted for an unknown lot number of lower back and hip (lbh) product.Conclusion: the root cause category is non-assignable (complaint not confirmed as a quality defect).There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality related trend identified for the subclass adverse event/serious/unknown.The 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.Review of complaint description concludes there is no device malfunction.Severity of harm was s3; site sample status was not received.Follow-up (05aug2019): new information received from the same contactable consumer included: medical history, product expiration date, and event details and outcome.Follow-up (08aug2019 and 09aug2019): new information received from a product quality complaint group includes: severity of harm (s3.) follow-up (16sep2019): new information from a contactable consumer includes: product information (lot no/ expiry/ upc, start date, indication) and patient information (date of birth, age, height, weight).Follow- up (16sep2019 and 24sep2019): new information from a contactable consumer received via glaxosmithkline, license party for thermacare, includes: patient information (gender), patient history (chronic pain), product information, additional event information (updated event description and event selection to "burn blister"), photos, hospitalization information (none), treatment information (none).This report is upgraded to a serious, reportable medical device report based on additional event description and photos received on 16sep2019.Follow-up (16sep2019): this case is being submitted to notify that the follow-up information previously considered to have been initially received by the company on 24sep2019 was instead received on 16sep2019.Follow-up(28oct2019): new information from a contactable consumer includes: product usage information and event details.Follow-up (29aug2019): new information received from a product quality complaint group includes product investigation results.Follow-up activities closed as follow-up attempts were already closed and completed.Amendment: this follow-up report is being submitted to amend previously reported information: updated malfunction to no., comment: based on the information provided, the event of "burn blister" as described is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.A causal relationship between the device and the event cannot be ruled out.There was limited device specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number and/or return sample a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Product effect varies with each individual.No further investigations or actions is suggested at this time.

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Brand Name

THERMACARE LOWER BACK & HIP

Type of Device

DISPOSABLE PACK, HOT

Manufacturer (Section D)

PFIZER CONSUMER HEALTH CARE

1231 wyandotte drive

albany GA 31705

MDR Report Key

9193243

MDR Text Key

173710954

Report Number

1066015-2019-00243

Device Sequence Number

Product Code

IMD

Combination Product (y/n)

PMA/PMN Number

K953442

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Lay User/Patient

Device Expiration Date

03/31/2020

Device Lot Number

7207SB; S97479

Was Device Available for Evaluation?

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

10/15/2019

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided
Not provided

Supplement Dates FDA Received

10/16/2019
11/13/2019
02/07/2020
02/28/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

34 YR

Patient Weight

MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE LOWER BACK & HIP; DISPOSABLE PACK, HOT

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