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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Discharge (2225); Burn, Thermal (2530)

Event Date 10/13/2018

Event Type  Injury  

Event Description

Event verbatim [preferred term] burn; huge burn spots on her back/noticed the 2 big areas on her back [thermal burn], areas have slight oozing but are almost covered over [wound secretion], did not check her skin under the product while wearing thermacare/wearing a snug waistband/belt or similar or otherwise applied pressure over the area [device use error].Case narrative: this is a spontaneous report from a contactable consumer reported for herself.A (b)(6) years-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), from (b)(6) 2018 to (b)(6) 2018 at applied to lower back below waist for bad back.Medical history included migraine since she was in her 20's, her speech got slurred with the migraines, diabetes type 2, blood pressure abnormal, disabled which occurred prior to using the wrap and sensitive skin.Concomitant medication included unspecific medication for blood pressure.The patient previously used thermacare heatwrap (thermacare heatwraps) which was a different wrap a long time ago for unknown indication and experienced no adverse effect.She had also previously used heating pad a long time ago and did not experienced any problem/symptom.The patient was reporting on thermacare lower back & hip wraps, size extra large.She and her husband were driving to a place on (b)(6) 2018.When they arrived at the hotel, she noticed she had burn, huge burn spots on her back on (b)(6) 2018.She can provide pictures if needed.She thought they would be helpful with driving because she had a bad back.After this she could hardly take a shower.They stayed overnight and then travelled on.It was nice to have the warmth.She no longer had the box.She took the wraps out of the box because it was too bulky to travel with.She had used thermacare wraps before.This was the first time using this type.She used the thermacare for 8 hours while in the car in one day.She was wearing a snug waistband/belt or similar or otherwise applied pressure over the area in situation of prolonged car ride on (b)(6) 2018.She attached the adhesive to around her waist.After arriving to the hotel, her husband was helping her remove the wrap and noticed the 2 big areas on her back on (b)(6) 2018.Areas had slight oozing but were almost covered over on (b)(6) 2018.She did not consult a healthcare professional for the problems.She cleansed area with alcohol, applied triple action antibiotic ointment and covered with big band aids.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare on (b)(6) 2018.She looked at pictures on the box before she used the product.She was currently under routine care of a physician for blood pressure and blood work.She classified her skin tone very light or olive.She did not have any abnormal skin conditions.She purchased red box.Packaging was sealed and intact.There was no product remaining.Device was not available for evaluation.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of the event burn; huge burn spots on her back/noticed the 2 big areas on her back was resolving and the outcome of the other 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 thermal burn, wound secretion and device use error 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 of thermal burn, wound secretion and device use error 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; huge burn spots on her back/noticed the 2 big areas on her back [thermal burn] , areas have slight oozing but are almost covered over [wound secretion] , did not check her skin under the product while wearing thermacare/wearing a snug waistband/belt or similar or otherwise applied pressure over the area [device use error].Case narrative:this is a spontaneous report from a contactable consumer reported for herself.A 53-year-old female patient started to receive thermacare heatwrap (thermacare lower back & hip), on (b)(6) 2018 applied to lower back below waist for 8 hours for bad back.Medical history included migraine since she was in her 20's, her speech got slurred with the migraines, ongoing diabetes type 2, ongoing blood pressure abnormal, disabled which occurred prior to using the wrap and sensitive skin.Concomitant medication included unspecific medication for blood pressure.The patient previously used thermacare heatwrap (thermacare heatwraps) which was a different wrap a long time ago for unknown indication and experienced no adverse effect.She had also previously used heating pad a long time ago and did not experienced any problem/symptom.The patient was reporting on thermacare lower back & hip wraps, size extra large.She and her husband were driving to a place on (b)(6) 2018.When they arrived at the hotel, she noticed she had burn, huge burn spots on her back on (b)(6) 2018.She can provide pictures if needed.She thought they would be helpful with driving because she had a bad back.After this she could hardly take a shower.They stayed overnight and then travelled on.It was nice to have the warmth.She no longer had the box.She took the wraps out of the box because it was too bulky to travel with.She had used thermacare wraps before.This was the first time using this type.She used the thermacare for 8 hours while in the car in one day.She was wearing a snug waistband/belt or similar or otherwise applied pressure over the area in situation of prolonged car ride on (b)(6) 2018.She attached the adhesive to around her waist.After arriving to the hotel, her husband was helping her remove the wrap and noticed the 2 big areas on her back on (b)(6) 2018.Areas had slight oozing but were almost covered over on (b)(6) 2018.She did not consult a healthcare professional for the problems.She cleansed area with alcohol, applied triple action antibiotic ointment and covered with big band aids.She did not engage in exercise while using the product.She did not check her skin under the product while wearing thermacare on (b)(6) 2018.She looked at pictures on the box before she used the product.She was currently under routine care of a physician for blood pressure and blood work.She classified her skin tone very light or olive.She did not have any abnormal skin conditions.She purchased red box.Packaging was sealed and intact.There was no product remaining.Device was not available for evaluation.The action taken in response to the events for thermacare heatwrap was permanently withdrawn on (b)(6) 2018.The outcome of the event burn; huge burn spots on her back/noticed the 2 big areas on her back was resolving and the outcome of the other events was unknown.According to the product quality complaint group: reasonably suggest device malfunction: no.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 assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.Follow-up (18mar2020): new information received from the product quality complaint group included investigational results.Follow-up attempts are completed.No further information is expected., comment: based on the information provided, the events of thermal burn, wound secretion and device use error 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.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.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 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 assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was 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: 8094532
• MDR Text Key: 128076087
• Report Number: 1066015-2018-00162
• 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
• Report Date: 11/14/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 70