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

Lot Number Q01096

Device Problem Use of Device Problem (1670)

Patient Problems Pressure Sores (2326); Skin Inflammation (2443); Patient Problem/Medical Problem (2688)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] open wound with now yellowish coating (like pus), distinct skin lesions, no bladders, now inflamated like decubitus [wound], open wound with now yellowish coating (like pus), distinct skin lesions, no bladders, now inflamated like decubitus [dermatitis], open wound with now yellowish coating (like pus), distinct skin lesions, no bladders, now inflamated like decubitus [purulence], used longer than 8 hours, fell asleep [device use error], thermacare back was administered on the lower abdomen [device use issue].This is a spontaneous report from a contactable pharmacist reported for his wife.A (b)(6)-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose after gallbladder surgery.Medical history included gallbladder surgery and ongoing slightly obese.Concomitant medications were not reported.Thermacare back was administered on the lower abdomen.The patient fell asleep, when thermacare was removed there were open spots with now yellowish coating (like pus), distinct skin lesions, no bladders, now inflamated like decubitus in (b)(6) 2018.The patch was worn longer than 8 hours, the patient had a gallbladder surgery, this was why she used thermacare.The action taken in response to the events of the product was unknown.The outcome of the events was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "open wound with now yellowish coating (like pus), distinct skin lesions, no bladders, now inflamed like decubitus" and "used longer than 8 hours, fell asleep" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event thermacare back was administered on the lower abdomen is non-serious.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events of "open wound with now yellowish coating (like pus), distinct skin lesions, no bladders, now inflamed like decubitus" and "used longer than 8 hours, fell asleep" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event thermacare back was administered on the lower abdomen is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event [preferred term] burn second to third degree/4 round burns, combusto grade ii to iii [burns second degree] , burn second to third degree/4 round burns, combusto grade ii to iii [burns third degree] , open wound with now yellowish coating (like pus), distinct skin lesions, no blisters, now inflamed like decubitus [wound] , open wound with now yellowish coating (like pus), distinct skin lesions, no blisters, now inflamed like decubitus [dermatitis] , open wound with now yellowish coating (like pus), distinct skin lesions, no blisters, now inflamed like decubitus [purulence] , distinct infections [infection] , thermacare back was administered on the lower abdomen/the patient read the usage instructions before using thermacare [intentional device use issue],.Case narrative:this is a spontaneous report from a contactable pharmacist reported for his wife and a contactable consumer (patient).A 44-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) lot number q01096, expiry date jul2019, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose after gallbladder surgery.Medical history included gallbladder surgery and ongoing slightly obese.Concomitant medications were none.Thermacare back was administered on the lower abdomen.The patient experienced burn second to third degree in (b)(6).The patient fell asleep, when thermacare was removed there were open spots with now yellowish coating (like pus), distinct skin lesions, no blister, now inflamed like decubitus in (b)(6) 2018.The patient had a gallbladder surgery, this was why she used thermacare.As of (b)(6) 2018, the patient reported she was not pregnant and not in her menopause.Her skin tone was medium, but no sensitive skin, nor any abnormal skin conditions.She used a red box product (lot number q01096, expiry date jul2019), thermacare for the back.She previously used thermacare and did not have similar problem/symptom experienced during previous use.The patient stated she used thermacare directly on the body for 6 hours and she had slept for 2 hours.The patient read the usage instructions before using thermacare.She was not taking any medication while using thermacare.She received the first treatment on (b)(6) 2018 and was in the hospital (pending clarification) for burns at the abdomen from (b)(6) 2018 to (b)(6) 2018.The daily treatment for the wound was still ongoing.The patient had no pain, after removal 4 round burns, combusto grade ii to iii, abdominal, with distinct infections.The action taken in response to the events of the product was unknown.The outcome of thermacare back was administered on the lower abdomen/the patient read the usage instructions before using thermacare was unknown.The outcome of other events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (on (b)(6) 2018): new information from the same pharmacist included: new event (burn second to third degree).Additional information has been requested and will be provided as it becomes available.Follow-up (on (b)(6) 2018): new information from a contactable consumer (patient) included: patient age, suspect product data (lot number, expiration date), past product history, deny of concomitant medication, new event (distinct infections), and treatment received.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of burns second degree, burns third degree, wound, dermatitis, purulence, and infection as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device., comment: based on the information provided, the events of burns second degree, burns third degree, wound, dermatitis, purulence, and infection as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.

Event Description

Event [preferred term] burn second to third degree [burns third degree] , open wound with now yellowish coating (like pus), distinct skin lesions, no blisters, now inflamed like decubitus [wound] , open wound with now yellowish coating (like pus), distinct skin lesions, no blisters, now inflamed like decubitus [dermatitis] , open wound with now yellowish coating (like pus), distinct skin lesions, no blisters, now inflamed like decubitus [purulence] , used longer than 8 hours, fell asleep/thermacare back was administered on the lower abdomen [device use error] ,.Case narrative:this is a spontaneous report from a contactable pharmacist reported for his wife.A 65-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip) via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose after gallbladder surgery.Medical history included gallbladder surgery and ongoing slightly obese.Concomitant medications were not reported.Thermacare back was administered on the lower abdomen.The patient experienced burn second to third degree in (b)(6).The patient fell asleep, when thermacare was removed there were open spots with now yellowish coating (like pus), distinct skin lesions, no blister, now inflamed like decubitus in (b)(6) 2018.The patch was worn longer than 8 hours, the patient had a gallbladder surgery, this was why she used thermacare.The action taken in response to the events of the product was unknown.The outcome of used longer than 8 hours, fell asleep/thermacare back was administered on the lower abdomen was unknown.The outcome of other events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (on (b)(6) 2018): new information from the same pharmacist included: new event (burn second to third degree).Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: based on the information provided, the events of "burn second to third degree", "open wound with now yellowish coating (like pus), distinct skin lesions, no bladders, now inflamed like decubitus" and "used longer than 8 hours, fell asleep" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event thermacare back was administered on the lower abdomen is non-serious.The events are medically assessed as associated with the use of the device, comment: based on the information provided, the events of "burn second to third degree", "open wound with now yellowish coating (like pus), distinct skin lesions, no bladders, now inflamed like decubitus" and "used longer than 8 hours, fell asleep" as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The event thermacare back was administered on the lower abdomen is non-serious.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

The root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reported burn.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Event [preferred term] burn second to third degree/4 round burns, combusto grade ii to iii [burns second degree] , burn second to third degree/4 round burns, combusto grade ii to iii [burns third degree] , open wound with now yellowish coating (like pus), distinct skin lesions, no blisters, now inflamed like decubitus [wound] , open wound with now yellowish coating (like pus), distinct skin lesions, no blisters, now inflamed like decubitus [dermatitis] , open wound with now yellowish coating (like pus), distinct skin lesions, no blisters, now inflamed like decubitus [purulence] , distinct infections [infection] , thermacare back was administered on the lower abdomen/the patient read the usage instructions before using thermacare [intentional device use issue] ,.Case narrative:this is a spontaneous report from a contactable pharmacist reported for his wife and a contactable consumer (patient).A 44-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number q01096, expiry date jul2019) from an unspecified date to an unspecified date after gallbladder surgery.The patient's medical history included gallbladder surgery and ongoing slightly obese.Concomitant medications were none.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.Thermacare back heatwrap was administered on the lower abdomen.The patient experienced burn second to third degree in (b)(6).The patient fell asleep, when thermacare heatwrap was removed there were open spots/wound with now yellowish coating (like pus), distinct skin lesions, no blister, now inflamed like decubitus in (b)(6) 2018.The patient had a gallbladder surgery, this was why she used thermacare.As of (b)(6) 2018, the patient reported she was not pregnant and not in her menopause.Her skin tone was medium, but no sensitive skin, nor any abnormal skin conditions.She used a red box product (lot number q01096, expiry date jul2019), thermacare for the back.She previously used thermacare and did not have similar problem/symptom experienced during previous use.The patient stated she used thermacare directly on the body for 6 hours and she had slept for 2 hours.The patient read the usage instructions before using thermacare.She was not taking any medication while using thermacare.She received the first treatment on (b)(6) 2018 and was in the hospital (pending clarification) for burns at the abdomen from (b)(6) 2018 to (b)(6) 2018.The daily treatment for the wound was still ongoing.The patient had no pain, after removal 4 round burns, combusto grade ii to iii, abdominal, with distinct infections.Action taken with the suspect product in response to the events was unknown.The outcome of thermacare back heatwrap was administered on the lower abdomen/patient read the usage instructions before using thermacare was unknown.The outcome of other events was not resolved.Additional information received from product quality complaint (pqc) group included investigation results.The root cause category is non assignable (complaint not confirmed).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reported burn.The cause of the burn is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Follow-up (on (b)(6) 2018): new information from the same pharmacist included: new event (burn second to third degree).Follow-up (on (b)(6) 2018): new information from a contactable consumer (patient) included: patient age, suspect product data (lot number, expiration date), past product history, deny of concomitant medication, new event (distinct infections), and treatment received.Follow-up (on (b)(6) 2019): new information received from product quality complaints (pqc) group included: product quality investigation results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of burns second degree, burns third degree, wound, dermatitis, purulence, and infection as described are considered serious bodily injury requiring medical intervention to prevent permanent damage or impairment of body structure.The event intentional device use issue is non-serious.The events are medically assessed as associated with the use of the device.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.

• 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: 8129307
• MDR Text Key: 129311656
• Report Number: 1066015-2018-00177
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2019
• Device Lot Number: Q01096
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/10/2018; 12/11/2018; 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR