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

Device Problem Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Pain (1994); Scarring (2061); Discomfort (2330); Sleep Dysfunction (2517); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.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 safety request for investigation.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.Sample status: not available.

Event Description

Blisters on his back, lumbar area and groin, including one on his chest under his pectoral muscle [blister], used heatwrap for back ache and pulled muscles in his chest, back, tummy and abs [device use error], struggling to sleep [insomnia], was in severe pain [pain], discomfort [discomfort], blisters are weeping [wound secretion], 7 scars on his chest, lower groin, hip and back [scar].Narrative: this is a spontaneous report from a contactable consumer or other non-hcp.A (b)(6) male patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from (b)(6) 2015 to (b)(6) 2015 for back ache and pulled muscles in his chest, back, tummy and abs (which he did getting out of bed).Medical history included diabetes.Concomitant medications were reported as none.On an unknown date, the patient wore the heatwrap for 8 hours and then removed the heatwrap at bedtime.When he removed the heatwrap, he found blisters on his back, lumbar area and groin, including one on his chest under his pectoral muscle.The patient was in severe pain and discomfort and was struggling to sleep.He noted the pain and discomfort got worse the next day.The blisters were weeping and he visited his general practitioner (gp) a couple days later (reported it was difficult getting an appointment) for further advice.The gp dressed the blisters for him.The patient mentioned he was currently changing the dressings every 4 hours and using jermalene.The patient was hospitalized due to the blistering, pain, discomfort and difficulty sleeping on an unspecified date for 5 weeks.He received unspecified treatment while in the hospital.He stated he now has 7 scars on his chest, lower groin, hip and back.The patient's skin was assessed as dark or olive.He did not have sensitive skin or any abnormal skin conditions.The patient had not previously used thermacare heatwraps or any other heat products.The patient did not engage in exercise while using the product and checked his skin under the heatwrap every 2 hours.Action taken with the suspect product was permanently withdrawn on 01apr2015.Therapeutic measures received included dressing at the patient's gp, unspecified treatment while hospitalized and self-dressing changes at home with jermalene.Clinical outcome of the event scar was unknown and for all other events was resolved on an unspecified date.Additional information received from product quality complaint (pqc) group included investigation results.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 8 hour product.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 safety request for investigation.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.Sample status: not available.Follow up (10apr2015): new information received from a contactable consumer includes: updated patient age, medical history, lot number and expiration date of lower back and hip heatwrap, additional suspect product of neck, shoulder and wrist heatwrap, suspect products start/stop date, additional suspect product indication, action taken with suspect products, additional details of therapeutic measures received, additional event of scar, patient hospitalization, and event outcome.Follow-up (22apr2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.Follow up (23apr2015): new information received from a contactable physician includes: the physician denied being provided any information regarding an adverse event with the use of the product and could not confirm the occurrence of the events reported by the patient.Follow-up (01jun2020): new information received from product quality complaints (pqc) group included: product quality investigation results.

Manufacturer Narrative

This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 12 hour product.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 safety request for investigation.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.Sample status: not available.

Event Description

Event verbatim [preferred term], blisters on his back, lumbar area and groin, including one on his chest under his pectoral muscle [blister], used heatwrap for back ache and pulled muscles in his chest, back, tummy and abs [device use error], struggling to sleep [insomnia], was in severe pain [pain], discomfort [discomfort], blisters are weeping [wound secretion], 7 scars on his chest, lower groin, hip and back [scar].Narrative: this is a spontaneous report from a contactable consumer or other non-hcp.A 61-year-old male patient started to use thermacare heatwrap (thermacare neck, shoulder & wrist) from (b)(6) 2015 for back ache and pulled muscles in his chest, back, tummy and abs (which he did getting out of bed).Medical history included diabetes.Concomitant medications were reported as none.On an unknown date, the patient wore the heatwrap for 8 hours and then removed the heatwrap at bedtime.When he removed the heatwrap, he found blisters on his back, lumbar area and groin, including one on his chest under his pectoral muscle.The patient was in severe pain and discomfort and was struggling to sleep.He noted the pain and discomfort got worse the next day.The blisters were weeping and he visited his general practitioner (gp) a couple days later (reported it was difficult getting an appointment) for further advice.The gp dressed the blisters for him.The patient mentioned he was currently changing the dressings every 4 hours and using jermalene.The patient was hospitalized due to the blistering, pain, discomfort and difficulty sleeping on an unspecified date for 5 weeks.He received unspecified treatment while in the hospital.He stated he now has 7 scars on his chest, lower groin, hip and back.The patient's skin was assessed as dark or olive.He did not have sensitive skin or any abnormal skin conditions.The patient had not previously used thermacare heatwraps or any other heat products.The patient did not engage in exercise while using the product and checked his skin under the heatwrap every 2 hours.Action taken with the suspect product was permanently withdrawn on 01apr 2015.Therapeutic measures received included dressing at the patient's gp, unspecified treatment while hospitalized and self-dressing changes at home with jermalene.Clinical outcome of the event scar was unknown and for all other events was resolved on an unspecified date.Additional information received from product quality complaint (pqc) group included investigation results.This investigation was conducted for an unknown lot number neck/shoulder/wrist (nsw) 12 hour product.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 safety request for investigation.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.Sample status: not available.Follow up (10apr2015): new information received from a contactable consumer includes: updated patient age, medical history, lot number and expiration date of lower back and hip heatwrap, additional suspect product of neck, shoulder and wrist heatwrap, suspect products start/stop date, additional suspect product indication, action taken with suspect products, additional details of therapeutic measures received, additional event of scar, patient hospitalization, and event outcome.Follow-up (22apr2015): new information received from product quality complaints (pqc) group included: quality assurance (qa) investigation results.Follow up (23apr2015): new information received from a contactable physician includes: the physician denied being provided any information regarding an adverse event with the use of the product and could not confirm the occurrence of the events reported by the patient.Follow-up (01jun2020): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up (11jun2020): new information received from product quality complaints (pqc) group included: updated investigation results [investigation product was updated from neck/shoulder/wrist (nsw) 12 hour from neck/shoulder/wrist (nsw) 8 hour].

• 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: 10143456
• MDR Text Key: 195380902
• Report Number: 1066015-2020-00128
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR