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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); Partial thickness (Second Degree) Burn (2694)

Event Date 01/23/2017

Event Type  Injury  

Event Description

Superficial 2d degree burn wound, less than 1% tbsa in the back [burns second degree] , patient did not use product as per instruction: should be used above clothing [device use error] , gram positive cocci staining showed staphylococcus aureus (some) [staphylococcus test positive] ,.Case narrative:the initial case was missing the following minimum criteria: unidentifiable patient.Upon receipt of follow-up information on 09feb2017, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable physician.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare heatwrap) on (b)(6) 2017 applied once for lower back pain.The patient's medical history was not reported.The patient took no concomitant medication.On (b)(6) 2017, the patient experienced a burn while using thermacare heatwraps (clarification pending).On (b)(6) 2017, the patient showed the superficial burn to the physician for the first time.At first, the patient was convinced she followed all instructions so she felt harmed.As the physician specifically asked, the patient checked the instructions again and she agreed she used the product wrongly.The second time the patient visited the physician she brought the packaging and the physician checked that the mention "above a cloth" was present.The physician specified the reported burn to "superficial 2d degree burn wound, less than 1% total body surface area (tbsa) in the back" with onset date (b)(6) 2017 and end date (b)(6) 2017.The event was assessed to be related to the fact that the patient "has not protected her skin by a cloth layer, duration of use in function of instructions according to the patient".Antibiogram tests (in 2017) were performed and showed sensitivity to amoxicilline+clavulanic acid, erythromycin, teicoplanin, vancomycin, trimethoprim+sulfa, mupirocin, tigecyclin and fusidic acid, but resistant to oxacillin.Penicillin antibiogram resulted in "1".Sample localisation: back.Gram positive cocci staining showed staphylococcus aureus (some).Anaerobic culture was negative.The patient was outpatient and was treated with mepilex (sterile bandage with a silicone layer; painkillers).Action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of second degree burns was resolved on (b)(6) 2017.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (06mar2017): new information received from a contactable physician includes: updated patient age, provided thermacare start date, indication, action taken; updated the event term from "burned herself with thermacare" to "superficial 2d degree burn wound, less than 1% tbsa in the back", outcome; added new event "gram positive cocci staining showed staphylococcus aureus (some)"; added lab data; no concomitant medication.Company clinical evaluation comment based on the information provided, the event "superficial 2d degree burn wound, less than 1% tbsa in the back" "patient did not use product as per instruction: should be used above clothing" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event are assessed as associated with the use of the device., comment: based on the information provided, the event "superficial 2d degree burn wound, less than 1% tbsa in the back" "patient did not use product as per instruction: should be used above clothing" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event are assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term] superficial 2d degree burn wound, less than 1% tbsa in the back [burns second degree] , patient did not use product as per instruction: should be used above clothing [device use error] , gram positive cocci staining showed staphylococcus aureus (some) [staphylococcus test positive].Case narrative:the initial case was missing the following minimum criteria: unidentifiable patient.Upon receipt of follow-up information on 09feb2017, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable physician.A (b)(6) female patient of an unspecified ethnicity started to use thermacare heatwrap (thermacare heatwrap) on (b)(6) 2017 applied once for lower back pain.The patient's medical history was not reported.The patient took no concomitant medication.On (b)(6) 2017, the patient experienced a burn while using thermacare heatwraps (clarification pending).On (b)(6) 2017, the patient showed the superficial burn to the physician for the first time.At first, the patient was convinced she followed all instructions so she felt harmed.As the physician specifically asked, the patient checked the instructions again and she agreed she used the product wrongly.The second time the patient visited the physician she brought the packaging and the physician checked that the mention "above a cloth" was present.The physician specified the reported burn to "superficial 2d degree burn wound, less than 1% total body surface area (tbsa) in the back" with onset date (b)(6) 2017 and end date (b)(6) 2017.The event was assessed to be related to the fact that the patient "has not protected her skin by a cloth layer, duration of use in function of instructions according to the patient".Antibiogram tests (in 2017) were performed and showed sensitivity to amoxicilline+clavulanic acid, erythromycine, teicoplanine, vancomycine, trimetoprime+sulfa, mupirocin, tigecyclin and fusidic acid, but resistant to oxacilline.Penicillin antibiogram resulted in "1".Sample localisation: back.Gram positive cocci staining showed staphylococcus aureus (some).Anaerobic culture was negative.The patient was outpatient and was treated with mepilex (sterile bandage with a silicone layer; painkillers).Action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of second degree burns was resolved on (b)(6) 2017.The outcome of other events was unknown.Additional information has been requested and will be provided as it becomes available.Follow-up (06mar2017): new information received from a contactable physician includes: updated patient age, provided thermacare start date, indication, action taken; updated the event term from "burned herself with thermacare" to "superficial 2d degree burn wound, less than 1% tbsa in the back", outcome; added new event "gram positive cocci staining showed staphylococcus aureus (some)"; added lab data; no concomitant medication.Follow-up (15mar2017): this follow-up is being submitted to notify that an investigation of the device is unable to be conducted.Follow-up attempts have been completed and no further information is expected.Company clinical evaluation comment: based on the information provided, the event "superficial 2d degree burn wound, less than 1% tbsa in the back" "patient did not use product as per instruction: should be used above clothing" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event are assessed as associated with the use of the device.Comment: based on the information provided, the event "superficial 2d degree burn wound, less than 1% tbsa in the back" "patient did not use product as per instruction: should be used above clothing" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event are assessed as associated with the use of the device.

Event Description

Event verbatim [preferred term].Superficial 2d degree burn wound, less than 1% tbsa in the back [burns second degree], patient did not use product as per instruction: should be used above clothing [device use error].Gram positive cocci staining showed staphylococcus aureus (some) [staphylococcus test positive].Narrative: the initial case was missing the following minimum criteria: unidentifiable patient.Upon receipt of follow-up information on 09feb2017, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable physician.A 76-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) on (b)(6) 2017 applied once for lower back pain.The patient's medical history was not reported.The patient took no concomitant medication.On (b)(6) 2017, the patient experienced a burn while using thermacare heatwraps (clarification pending).On (b)(6) 2017, the patient showed the superficial burn to the physician for the first time.At first, the patient was convinced she followed all instructions so she felt harmed.As the physician specifically asked, the patient checked the instructions again and she agreed she used the product wrongly.The second time the patient visited the physician she brought the packaging and the physician checked that the mention "above a cloth" was present.The physician specified the reported burn to "superficial 2d degree burn wound, less than 1% total body surface area (tbsa) in the back" with onset date (b)(6) 2017 and end date (b)(6) 2017.The event was assessed to be related to the fact that the patient "has not protected her skin by a cloth layer, duration of use in function of instructions according to the patient".Antibiogram tests (in 2017) were performed and showed sensitivity to amoxicilline+clavulanic acid, erythromycine, teicoplanine, vancomycine, trimetoprime+sulfa, mupirocin, tigecyclin and fusidic acid, but resistant to oxacilline.Penicillin antibiogram resulted in "1".Sample localisation: back.Gram positive cocci staining showed staphylococcus aureus (some).Anaerobic culture was negative.The patient was outpatient and was treated with mepilex (sterile bandage with a silicone layer; painkillers).Action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2017.The outcome of second degree burns was resolved on (b)(6) 2017.The outcome of other events was unknown.Additional information received from product quality complaint (pqc) group included investigation results.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, 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 them product being packaged.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Sample status: not received.Follow-up (06mar2017): new information received from a contactable physician includes: updated patient age, provided thermacare start date, indication, action taken; updated the event term from "burned herself with thermacare" to "superficial 2d degree burn wound, less than 1% tbsa in the back", outcome; added new event "gram positive cocci staining showed staphylococcus aureus (some)"; added lab data; no concomitant medication, case upgraded to reportable.Follow-up (15mar2017): this follow-up is being submitted to notify that an investigation of the device is unable to be conducted.Follow-up attempts have been completed and no further information is expected.Follow up (18jul2020): new information received from product quality complaints (pqc) group included: updated suspect product and provided product quality investigation results.No follow up attempts possible.No further information is expected.Follow-up (23jun2020): this case is being submitted to notify that the follow-up information previously considered to have been initially received by the company on 18jul2020 was instead received on 23jun2020.No follow up attempts possible.No further information is expected., comment: based on the information provided, the event "superficial 2d degree burn wound, less than 1% tbsa in the back" "patient did not use product as per instruction: should be used above clothing" as described in this case are considered a serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure, and the event are assessed as associated with the use of the device.

Manufacturer Narrative

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, 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 them product being packaged.Reasonably suggest device malfunction?: no.Severity of harm: n/a.Sample status: not received.

• 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: 6402252
• MDR Text Key: 69866261
• Report Number: 1066015-2017-00056
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2017

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2017; 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR