MAUDE Adverse Event Report: PFIZER CONSUMER HEALTH CARE THERMACARE NECK, SHOULDER & WRIST; DISPOSABLE PACK, HOT

Device Problems Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problems Burn, Thermal (2530); Caustic/Chemical Burns (2549)

Event Date 11/03/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] i felt like i was chemically burning/my skin was red and raw [thermal burn] , adhesive stuck like nobody's business [product adhesion issue] ,.Case narrative: this is a spontaneous report from a contactable consumer.This is a report received from the us fda.Regulatory authority report number is mw5081722.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare heatwrap), expiration date 30nov2018, via transdermal from 2013 at an unknown frequency for pain relief.The patient medical history was not reported.Concomitant medication included fluoxetine hydrochloride (prozac), gabapentin, lamotrigine (lamictal), omeprazole (protonix), lorazepam (ativan), quetiapine fumarate (seroquel), paracetamol (tylenol), acetylsalicylic acid, caffeine, paracetamol (excedrin), diphenhydramine hydrochloride (benadryl).The patient stated, "i generally use the thermacare patches.It's my fallback to try and avoid putting more chemicals into my stomach.I am so glad this report came out, as i didn't know what the burning was from.I used one box and thought well, it's probably just me.A week or so later, i put one on my back and actually started to cry.I tried to get it off, and the adhesive stuck like nobody's business.My skin was red and raw and i felt like i was chemically burning on (b)(6) 2018.My husband put cold, wet paper towels on my back and that made it worse".Event report type was reported as serious injury.Event outcome was reported as other serious (important medical event).The patient stopped using the product on an unspecified date in 2018.The event outcome was unknown.Device was not applicable for evaluation.No follow-up attempts are possible.No further information is expected.

Event Description

Event verbatim [preferred term].I felt like i was chemically burning/my skin was red and raw [thermal burn], adhesive stuck like nobody's business [product adhesion issue].Case narrative:this is a spontaneous report from a contactable consumer.This is a report received from the us fda.Regulatory authority report number is mw5081722.A patient of unspecified age and gender started to receive thermacare heatwrap (thermacare neck, shoulder, & wrist), expiration date 30nov2018, via transdermal from 2013 at an unknown frequency for pain relief.The patient medical history was not reported.Concomitant medication included fluoxetine hydrochloride (prozac), gabapentin, lamotrigine (lamictal), omeprazole (protonix), lorazepam (ativan), quetiapine fumarate (seroquel), paracetamol (tylenol), acetylsalicylic acid, caffeine, paracetamol (excedrinil), diphenhydramine hydrochloride (benadryl).The patient stated, "i generally use the thermacare patches.It's my fallback to try and avoid putting more chemicals into my stomach.I am so glad this report came out, as i didn't know what the burning was from.I used one box and thought well, it's probably just me.A week or so later, i put one on my back and actually started to cry.I tried to get it off, and the adhesive stuck like nobody's business.My skin was red and raw and i felt like i was chemically burning on (b)(6) 2018.My husband put cold, wet paper towels on my back and that made it worse".Event report type was reported as serious injury.Event outcome was reported as other serious (important medical event).The patient stopped using the product on an unspecified date in 2018.The event outcome was unknown.Device was not applicable for evaluation.Upon follow-up, product quality complaints provided the following investigation information: initial complaint assessment: sample was not available.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: investigation/ sub class: adverse event safety request for investigation.The pcom search returned a total of 74 complaints for neck shoulder wrist 8 hour products during this time period for the class/subclass.Of the 74 complaints; 15 complaints have the batch number recorded as "unknown." the 59 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event for nsw 8 hour products.There is no further action required.Based on this pcom search for the subclass of adverse event for nsw 8 hour products the data did show an increase over time (36 months).Adverse events for burns show peaks in november and december 2018.Thermacare burn rate surveillance was included in management review on 23jan2019.In the most recent 6 month period (jun-dec 2018), an increase in % burn reports follows upward trend of total sales.However, cases/million wraps continues to be very stable at 3.61 less than maximum (<10).No trend; the burn rate is within ppm.There is not a trend identified for the subclass of adverse event for nsw 8 hour products (adverse event (b)(6) 2015 - (b)(6) 2018).Investigation summary: the root cause category is non-assignable.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass of adverse event for nsw 8 hour products.There is not a trend identified for the subclass of adverse event for nsw 8 hour products.Adverse events for burns show peaks in november and december 2018.Thermacare burn rate surveillance was included in management review on 23jan2019.In the most recent 6 month period (jun-dec 2018), an increase in % burn reports follows upward trend of total sales.However, cases/million wraps continues to be very stable at 3.61 less than maximum [<10].No trend; the burn rate is within ppm.The complaint was not confirmed.No follow-up attempts are possible.No further information is expected.Follow-up (04mar2019): new information from product quality complaint group includes: updated thermacare product and investigation results.

Manufacturer Narrative

Sample was not available.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed: investigation/ sub class: adverse event safety request for investigation.The pcom search returned a total of 74 complaints for neck shoulder wrist 8 hour products during this time period for the class/subclass.Of the 74 complaints; 15 complaints have the batch number recorded as "unknown".The 59 remaining complaints were evaluated.There were no complaints confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this pcom search, there is not a trend identified for the subclass of adverse event for nsw 8 hour products.There is no further action required.Based on this pcom search for the subclass of adverse event for nsw 8 hour products the data did show an increase over time (36 months).Adverse events for burns show peaks in november and december 2018.Thermacare burn rate surveillance was included in management review on 23jan2019.In the most recent 6 month period (jun-dec 2018), an increase in % burn reports follows upward trend of total sales.However, cases/million wraps continues to be very stable at 3.61 less than maximum (<10).No trend; the burn rate is within ppm.There is not a trend identified for the subclass of adverse event for nsw 8 hour products (adverse event (b)(6) 2015 - (b)(6) 2018).Investigation summary: the root cause category is non-assignable.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.There is not a trend identified for the subclass of adverse event for nsw 8 hour products.There is not a trend identified for the subclass of adverse event for nsw 8 hour products.Adverse events for burns show peaks in november and.

• Brand Name: THERMACARE NECK, SHOULDER & WRIST
• Type of Device: DISPOSABLE PACK, HOT
• Manufacturer (Section D): PFIZER CONSUMER HEALTH CARE; 1231 wyandotte drive; albany GA 31705
• MDR Report Key: 8206590
• MDR Text Key: 131788552
• Report Number: 1066015-2018-00215
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K953442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATIVAN.; ATIVAN.; BENADRYL.; BENADRYL.; EXCEDRINIL.; EXCEDRINIL.; GABAPENTIN.; GABAPENTIN.; LAMICTAL.; LAMICTAL.; PROTONIX [OMEPRAZOLE].; PROTONIX [OMEPRAZOLE].; PROZAC.; PROZAC.; SEROQUEL.; SEROQUEL.; TYLENOL [PARACETAMOL].; TYLENOL [PARACETAMOL].
• Patient Outcome(s): Other; Required Intervention