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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Pain (1994); Skin Irritation (2076); No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Event Description

Had blistering on their back [blister], lower back erythema [erythema], irritation [irritability], pain [pain].Case narrative: this is a spontaneous report from a contactable pharmacist via a sales representative.A 41-year-old male patient started to receive thermacare heatwrap (thermacare heatwrap) from unknown date to (b)(6) 2018 for back ache.Medical history included cystic fibrosis.Concomitant medications included ongoing subcutaneous insulins, oral pancreatin (creon 10) 150mg ongoing from (b)(6) 2013, oral esomeprazole 40mg ongoing from (b)(6) 2018, oral ivacaftor, lumacaftor (orkambi) 200/125mg ongoing from (b)(6) 2017, and oral dekas plus ongoing from (b)(6) 2017 for cystic fibrosis.The patient experienced lower back blistering and erythema on the skin after using the heatwrap in approximately (b)(6) 2018.The patient applied the thermacare heatwrap in the morning and by lunchtime had blistering on his back.The reporter considered the events serious, medically significant due to significant pain and irritation.At the time of reporting the event was a new occurrence surgical intervention was not required.The patient was not expected to experience long-term sequelae.Treatment was not required.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2018.The outcome of the events was resolved in (b)(6) 2018.Additional information has been requested and will be provided as it becomes available.Follow-up (22jul2019): new information received from the same contactable pharmacist included: patient age, suspect product data (indication, action taken, stop date), medical history, concomitant medications, new events (erythema on the skin, pain and irritation), event details (onset date, outcome, stop date), deny of treatment received, seriousness assessment, and case upgraded to a serious, reportable mdr.Company clinical evaluation comment: based on the information provided, the events blister, erythema, irritability and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure the events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events blister, erythema, irritability and device issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.

Manufacturer Narrative

This investigation was conducted for an unknown lot number of lbh.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/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.

Event Description

Had blistering on their back [blister] , lower back erythema [erythema] , irritation [irritability] , pain [pain].Case narrative: this is a spontaneous report from a contactable pharmacist via a sales representative.A 41-year-old male patient started to receive thermacare heatwrap (thermacare lower back & hip) from unknown date to (b)(6) 2018 for back ache.Medical history included cystic fibrosis, gastric acid.Concomitant medications included ongoing subcutaneous insulins, oral pancreatin (creon 10) 150mg ongoing from (b)(6) 2013 to replace enzymes, oral esomeprazole 40mg ongoing from (b)(6) 2018 to reduce gastric acid, oral ivacaftor, oral lumacaftor (orkambi) 200/125mg ongoing from (b)(6) 2017, and oral dekas plus ongoing from (b)(6) 2017 for cystic fibrosis.The pharmacist clarified concomitant medications were not being used off license for cystic fibrosis.Rather the nature of the disease has affected many organs.To qualify the indications of the concomitant meds further, esomeprazole was used to reduce gastric acid and pancreatin to replace enzymes; symptoms that were a consequence of cystic fibrosis.The patient experienced lower back blistering and erythema on the skin after using the heatwrap in approximately (b)(6) 2018.The patient applied the thermacare heatwrap in the morning and by lunchtime had blistering on his back.The reporter considered the events serious, medically significant due to significant pain and irritation.The event was a new occurrence surgical intervention was not required.The patient was not expected to experience long-tern sequelae.Treatment was not required.The action taken in response to the events of the product was permanently discontinued on mar2018.The outcome of the events was resolved in (b)(6) 2018.According to pfizer quality operations, this investigation was conducted for an unknown lot number of lbh.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/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.Follow-up (22jul2019): new information received from the same contactable pharmacist included: patient age, suspect product data (indication, action taken, stop date), medical history, concomitant medications, new events (erythema on the skin, pain and irritation), event details (onset date, outcome, stop date), deny of treatment received, seriousness assessment, and case upgraded to a serious, reportable mdr.Follow-up (02aug2019 and 05aug2019): new information received from a contactable pharmacist and from pfizer quality operations includes additional information regarding concomitant medications and investigation results.Follow-up (24sep2019): new information received from a contactable pharmacist included: trade name of suspect product.Comment: based on the information provided, the events blister, erythema, irritability and pain as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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.The root cause category is non-assignable (complaint not confirmed as a quality defect).Product effect varies with each individual.No remedial action/corrective action/field safety corrective action is suggested at this time.

Manufacturer Narrative

This investigation was conducted for an unknown lot number of lbh.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/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.

Event Description

Event verbatim [preferred term] had blistering on their back [blister] , lower back erythema [erythema] , irritation [irritability] , pain [pain] ,.Case narrative:this is a spontaneous report from a contactable pharmacist via a sales representative.A 41-year-old male patient started to receive thermacare heatwrap (thermacare heatwrap) from unknown date to (b)(6) 2018 for back ache.Medical history included cystic fibrosis.Concomitant medications included ongoing subcutaneous insulins, oral pancreatin (creon 10) 150mg ongoing from (b)(6) 2013 to replace enzymes, oral esomeprazole 40mg ongoing from (b)(6) 2018 to reduce gastric acid, oral ivacaftor, lumacaftor (orkambi) 200/125mg ongoing from (b)(6) 2017, and oral dekas plus ongoing from (b)(6) 2017 for cystic fibrosis.The pharmacist clarified concomitant medications were not being used off license for cystic fibrosis.Rather the nature of the disease has affected many organs.To qualify the indications of the concomitant meds further, esomeprazole was used to reduce gastric acid and pancreatin to replace enzymes; symptoms that were a consequence of cystic fibrosis.The patient experienced lower back blistering and erythema on the skin after using the heatwrap in approximately (b)(6) 2018.The patient applied the thermacare heatwrap in the morning and by lunchtime had blistering on his back.The reporter considered the events serious, medically significant due to significant pain and irritation.The event was a new occurrence surgical intervention was not required.The patient was not expected to experience long-tern sequelae.Treatment was not required.The action taken in response to the events of the product was permanently discontinued on (b)(6) 2018.The outcome of the events was resolved in (b)(6) 2018.According to pfizer quality operations, this investigation was conducted for an unknown lot number of lbh.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/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.Follow-up (22jul2019): new information received from the same contactable pharmacist included: patient age, suspect product data (indication, action taken, stop date), medical history, concomitant medications, new events (erythema on the skin, pain and irritation), event details (onset date, outcome, stop date), deny of treatment received, seriousness assessment, and case upgraded to a serious, reportable mdr.Follow-up (02aug2019 and 05aug2019): new information received from a contactable pharmacist and from pfizer quality operations includes additional information regarding concomitant medications and investigation results., comment: based on the information provided, the events blister, erythema, irritability and pain as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.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.The root cause category is non-assignable (complaint not confirmed as a quality defect).Product effect varies with each individual.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: 8885295
• MDR Text Key: 154856262
• Report Number: 1066015-2019-00209
• 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
• Report Date: 03/13/2018

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/20/2019; 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CREON 10; CREON 10; CREON 10; ESOMEPRAZOLE; ESOMEPRAZOLE; ESOMEPRAZOLE; INSULIN; INSULIN; INSULIN; ORKAMBI; ORKAMBI; ORKAMBI
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR