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

Lot Number N07338

Device Problems Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 06/24/2016

Event Type  Injury  

Event Description

Burn on lower right back/ the burn did not blister/redness went away on my back [thermal burn], she did not read everything on the package and noticed there were different instructions for users over 55 after using it [product label issue].Case narrative:this is a spontaneous report from a contactable consumer.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n07338, expiration date: dec2017) from an unspecified date for lower back pain on right side.Medical history included knee replacement, unknown if ongoing (first knee replaced in 1995 or 1996, right knee; second knee replacement, left knee, in 2010 or 2011), diabetes and blood pressure abnormal.Concomitant medication included ibuprofen tablet orally from 2015 and ongoing at 600mg as needed for back pain, metformin for diabetes, rosuvastatin calcium (crestor), and blood pressure medications.On (b)(6) 2016, the patient experienced burn on lower right back after using the heatwrap for 3 hours.The burn did not blister and was starting to fade a little (stated looked like it is half gone), but was red and sensitive.She put some ointment on back where it burned and in a week to 10 days the redness went away on her back.She stated she did not read everything on the package and noticed there were different instructions for users over 55 after using it.The patient mentioned when she had the heat on her lower back the back pain felt better.There was no admission to hospital for the events.The action taken in response to the events for thermacare heatwrap was permanently withdrawn in 2016.Measures taken for the event "burn on lower right back/ the burn did not blister/redness went away on my back".No treatment for the event "she did not read everything on the package and noticed there were different instructions for users over 55 after using it".The outcome of the events was resolved in 2016.Additional information has been requested and will be provided as it becomes available.Follow-up (27sep2016): new information received from a contactable consumer includes: updated concomitant medications, events outcome, events treatment information.Subsumed event term the redness went away on her back into event burn on lower right back.There was no admission to hospital for the events.Follow-up (23nov2016): follow-up attempts are completed.No further information is expected.Follow-up (29jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment: based on the information provided, the events thermal burn and product label issue as described are considered serious bodily injury 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 thermal burn and product label issue as described are considered serious bodily injury 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.

Event Description

Event verbatim [preferred term] burn on lower right back/ the burn did not blister/redness went away on my back [thermal burn] ,.Case narrative:this is a spontaneous report from a contactable consumer.A 77-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n07338, expiration date: dec2017) from an unspecified date for lower back pain on right side.Medical history included knee replacement, unknown if ongoing (first knee replaced in 1995 or 1996, right knee; second knee replacement, left knee, in 2010 or 2011), diabetes and blood pressure abnormal.Concomitant medication included ibuprofen tablet orally from 2015 and ongoing at 600mg as needed for back pain, metformin for diabetes, rosuvastatin calcium (crestor), and blood pressure medications.On (b)(6) 2016, the patient experienced burn on lower right back after using the heatwrap for 3 hours.The burn did not blister and was starting to fade a little (stated looked like it is half gone), but was red and sensitive.She put some ointment on back where it burned and in a week to 10 days the redness went away on her back.She stated she did not read everything on the package and noticed there were different instructions for users over 55 after using it.The patient mentioned when she had the heat on her lower back the back pain felt better.There was no admission to hospital for the events.The action taken in response to the event for thermacare heatwrap was permanently withdrawn in 2016.Measures taken for the event "burn on lower right back/ the burn did not blister/redness went away on my back".The outcome of the event was resolved in 2016.Additional information has been requested and will be provided as it becomes available.Follow-up (27sep2016): new information received from a contactable consumer includes: updated concomitant medications, events outcome, events treatment information.Subsumed event term the redness went away on her back into event burn on lower right back.There was no admission to hospital for the events.Follow-up (23nov2016): follow-up attempts are completed.No further information is expected.Follow-up (29jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: event "she did not read everything on the package and noticed there were different instructions for users over 55 after using it" removed and medwatch report type (product problem) unticked.Company clinical evaluation comment: based on the information provided, the events thermal burn and product label issue as described are considered serious bodily injury 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 thermal burn and product label issue as described are considered serious bodily injury 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 lower back/hip (lbh) 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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Sample status was not available.

Event Description

Event verbatim [preferred term].Burn on lower right back/ the burn did not blister/redness went away on my back [thermal burn].Narrative: this is a spontaneous report from a contactable consumer.A 77-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) (device lot number: n07338, expiration date: dec2017) from an unspecified date for lower back pain on right side.Medical history included knee replacement (first knee replaced in 1995 or 1996, right knee; second knee replacement, left knee, in 2010 or 2011), diabetes and blood pressure abnormal.Concomitant medication included ibuprofen tablet orally from 2015 and ongoing at 600mg as needed for back pain, metformin for diabetes, rosuvastatin calcium (crestor), and blood pressure medications.On (b)(6) 2016, the patient experienced burn on lower right back after using the heatwrap for 3 hours.The burn did not blister and was starting to fade a little (stated looked like it is half gone), but was red and sensitive.She put some ointment on back where it burned and in a week to 10 days the redness went away on her back.She stated she did not read everything on the package and noticed there were different instructions for users over 55 after using it.The patient mentioned when she had the heat on her lower back the back pain felt better.There was no admission to hospital for the events.The action taken in response to the event for thermacare heatwrap was permanently withdrawn in 2016.Measures taken for the event "burn on lower right back/ the burn did not blister/redness went away on my back".The outcome of the event was resolved in 2016.Additional information received from product quality complaint (pqc) group included investigation results.This investigation was conducted for an unknown lot number lower back/hip (lbh) 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.Lot trend assessment and rationale: a lot trend was not performed as the lot number is unknown.Sample status was not available.Follow-up (27sep2016): new information received from a contactable consumer includes: updated concomitant medications, events outcome, events treatment information.Subsumed event term the redness went away on her back into event burn on lower right back.There was no admission to hospital for the events.Follow-up (23nov2016): follow-up attempts are completed.No further information is expected.Follow-up (29jun2016): this follow-up report is being submitted to upgrade this case to a reportable mdr.Amendment: this follow-up report is being submitted to amend previously reported information: event "she did not read everything on the package and noticed there were different instructions for users over 55 after using it" removed and medwatch report type (product problem) unticked.Follow-up (18mar2020): new information received from product quality complaints (pqc) group included: product quality investigation results.No follow-up attempts are possible.No further information anticipated.

• 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: 9259545
• MDR Text Key: 184503801
• Report Number: 1066015-2019-00416
• 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: 06/29/2016

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
• Device Expiration Date: 12/01/2017
• Device Lot Number: N07338
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/14/2019; 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CRESTOR; CRESTOR; CRESTOR [DOSAGE FORM:]; IBUPROFEN; IBUPROFEN; IBUPROFEN [DOSAGE FORM:] TABLET; METFORMIN; METFORMIN; METFORMIN [DOSAGE FORM:]
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 103