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

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

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Burns on back/scarring on the back from the burns [thermal burn].Case narrative: this is a spontaneous report from a contactable consumer.A female patient of unknown age started to receive thermacare heatwrap (thermacare heatwrap) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.The patient received burns from using the product on her back and so, she went and received treatment for it and she had some scarring on her back from the burns.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Reportability determination from pfizer device complaint handling unit (dchu): this complaint of burns on her back for thermacare is reportable in the us due to serious injury that necessitates medical intervention to preclude permanent damage to a body structure.This complaint is also reportable in the row since it is an anticipated serious deterioration of in state of health.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the event of "burn" as described is considered serious bodily injury 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" as described is considered serious bodily injury 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.

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: complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor.The citi customizable search returned a total of 839 complaints for lower back/hip (lbh) products during this time period for the class/subclass.None of the complaints 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 subclass shows an increase in january 2017 through april 2017, november 2017 through april 2018 and october 2018 through april 2019.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 and an overall increase of subsequent complaints received at the site.Nine of the 16 complaints received in (b)(6) 2017 were related to burns and blisters.The data shows a spike of complaints received in (b)(6) 2019.Ninety of the 206 complaints received were related to burns, blisters, and redness; forty-three has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Seventeen of the 66 complaints received in (b)(6) 2019 were related burns, blister, and redness; nineteen has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Thirteen of the 59 complaints received in (b)(6) 2019 were related burns, blister, and redness.(b)(6) 2019 shows an increase attributed to consumers reporting adverse events after being notified of a product recall.Consumers referenced.

Event Description

Event verbatim [preferred term]: burns on back/scarring on the back from the burns [thermal burn].Case narrative:this is a spontaneous report from a contactable consumer.A female patient of unknown age started to receive thermacare heatwrap (thermacare lower back & hip heatwrap) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.The patient received burns from using the product on her back, and so she went and received treatment for it and she had some scarring on her back from the burns.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.This complaint of burns on her back for thermacare is a serious injury that necessitates medical intervention to preclude permanent damage to a body structure.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: complaint class: external cause investigation / complaint sub class: adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor.The citi customizable search returned a total of 839 complaints for lower back/hip (lbh) products during this time period for the class/subclass.None of the complaints 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 subclass shows an increase in january 2017 through april 2017, november 2017 through april 2018 and october 2018 through april 2019.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 and an overall increase of subsequent complaints received at the site.Nine of the 16 complaints received in (b)(6) 2017 were related to burns and blisters.The data shows a spike of complaints received in (b)(6) 2019.Ninety of the 206 complaints received were related to burns, blisters, and redness; forty -three has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Seventeen of the 66 complaints received in (b)(6) 2019 were related burns, blister, and redness; nineteen has a severity ranking of s1-too cool, heat/cold did not last long enough, never worked.Thirteen of the 59 complaints received in (b)(6) 2019 were related burns, blister, and redness.(b)(6) 2019 shows an increase attributed 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 april 2019.Exped trend actions taken: based on this citi search, there is not a trend identified for the subclass adverse event/serious/unknown, adverse event safety request for investigation and adverse event negligible-minor for lbh 8hr products.There is no further action is required.Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour 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.Severity of harm: s3; review of complaint description concludes there is no device malfunction.Site sample status: not received.Follow up attempts are completed.No further information is expected.Follow-up (27jan2020): new information reported from product quality complaint group includes product information and product investigation results.

Manufacturer Narrative

Summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.

Event Description

Event verbatim [preferred term].Burns on back/scarring on the back from the burns/skin problem/rash/sustaining back pain/pain and blistering/multiple blisters (bullous) varing sizes with erythermatous ring around lesions [burns second degree], cellulitis [cellulitis], narrative: this is a spontaneous report from a contactable consumer.A 41-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip heatwrap) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history included anemia, anxiety disorder, asthma, depression, knee pain and bronchitis.The patient's concomitant medications were not reported.The patient previously took morphine and experienced allergies, also took azithromycin 250 mg tablet at 2 tablets by mouth today (unknown date), then take a tablet daily for 4 days; cyclobenzaprine 10 mg tablet; fluoxetine 10 mg capsule at one capsule by mouth every day; fluticasone propionate 50 mcg/actuation nasal spray, suspension, spray 1 sprays every day by intranasal route; ibuprofen 800 mg tablet; ethinylestradiol,ferrous fumarate,norethisterone acetate (melodetta 24 fe) 1mg-20mcg (24)/75 mg at 4 chewable tablet; ofloxacin 0.3% eye drops; ondansetron hcl 4 mg tablet; phentermine 37.5 mg capsule at 1 capsule every day by oral route for 30 days; salbutamol sulfate (proair hfa) 90 mcg/actuation aerosol inhaler at 2 puffs by mouth every 4-6 hours and sulfamethoxazole 800 mg-trimethoprim 160 mg tablet.The patient received burns from using the product on her back, and so she went and received treatment for it and she had some scarring on her back from the burns.It was further reported that on (b)(6) 2019, the patient went to clinic for skin problem/rash.She came on (b)(6) 2019 to get eval after sustaining burn on her back-blisters on the back that had started blistering up; she started after sustaining back pain-she went to er and was told to put pain patch that later caused pain and blistering.The patient underwent lab tests and procedures on (b)(6) 2019 which included blood pressure (bp) was 132/86 sitting left arm, body mass index (bmi) was 42.9, pulse was 58 bpm regular, respiratory rate (rr) was 16, psychiatric indicated insight: good judgement.Mental status: normal mood and affect and active and alert.Orientation: to time, place, and person.Memory: recent memory normal and remote memory normal.Other physical exam included constitutional: general appearance: healthy-appearing, well-nourished, and well-developed.Level of distress: nad.Ambulation: ambulating normally.Head: normocephalic and atraumatic.Neck: supple, from, trachea midline, and no masses.Lymph nodes: no cervical lad, supraclavicular lad, axillary lad, or inguinal lad.Thyroid: no enlargement or nodules and non-tender.Lungs: respiratory effort: no dyspnea.Percussion: no dullness, flatness, or hyperresonance.Auscultation: no wheezing, rales/crackles, or rhonchi and breath sounds normal, good air movement, and cta except as noted.Cardiovascular: apical impulse: not displaced.Heart auscultation: normal s1 and s2: no murmurs, rubs, or gallops, and rrr.Neck vessels: no carotid bruits.Pulses including femoral/pedal: normal throughout.Neurologic: gait and station: normal gait and station.Cranial nerves: grossly intact.Sensation: grossly intact.Coordination and cerebellum: no tremor.Skin: inspection and palpation: no rash, ulcer, nodules, jaundice, or abnormal nevi;lesion and indurated; and good turgor; multiple blisters (bullous) varing sizes with erythermatous ring around lesions.Back: thoracolumbar appearance; normal curvature.The doctor assessed the event as burn of skin-lesions 1 and d (b)(6) 2019 and tolerated well with no blood loss-local treatment and f/u prn; and cellulitis-zpack and flexeril 10 mg 1 qhs.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Product investigation results were as follows: summary of investigation: this investigation was conducted for an unknown lot number lower back/hip (lbh) 8 hour 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.Lot trend assmt.& rationale: a lot trend was not performed as the lot number is unknown.Severity of harm was s3.Site sample status was not received.Follow up attempts are completed.No further information is expected.Follow-up (27jan2020): new information reported from product quality complaint group includes product information and product investigation results.Follow-up (02jul2020): this is a follow-up report from a contactable consumer includes patient data (age, weight, height), medical history, past drug data, lab data, reaction data (added event cellulitis, event updated from burn to burn blister), added event information and treatment details and updated investigational results.

• 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: 9628310
• MDR Text Key: 189165486
• Report Number: 1066015-2020-00013
• 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,Followup
• Report Date: 01/13/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/07/2020; 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 124