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

Device Problems Use of Device Problem (1670); Human Factors Issue (2948)

Patient Problems Erosion (1750); Skin Discoloration (2074); Tissue Damage (2104); Burn, Thermal (2530)

Event Date 11/08/2016

Event Type  Injury  

Event Description

Event verbatim burns on stomach, the size of her first finger in length [thermal burn] , wrap had eaten through stomach; took skin completely off [skin exfoliation] , was sleeping while wearing product [intentional device misuse] , using heatwrap to numb stomach pain from uti [device use issue] ,.Case narrative:this is a spontaneous report from a contactable consumer or other non hcp.A (b)(6) female patient started to use thermacare heatwrap (thermacare lower back & hip) from (b)(6) 2016 to numb stomach pain from urinary tract infection (uti).Medical history included graves' disease from an unknown date and unknown if ongoing (taking methamizole), urinary tract infection from an unknown date and unknown if ongoing (taking cipro) and sensitive skin from an unknown date and ongoing.Concomitant medication included thiamazole (methimazole) and ciprofloxacin (cipro).Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported she applied the heatwrap around her waist and back before going to bed to numb her stomach pain from her uti.On (b)(6) 2016, the patient reported she awoke in the middle of the night, around 3:17 am, and her stomach was on fire and when she actually woke up at 4:45 am she noticed the wrap had eaten through her stomach, took the skin completely off.She did not know the level of degree of burns to her stomach but described the burns as the size of her first finger in length.She stated she wore the heatwrap over a t-shirt and light lace underwear.The patient mentioned she was sleeping while wearing product and used the product for a total of 4 hours.She had not consulted a healthcare professional, she stated she was on her way to see an hcp at the time of the report.The patient assessed her skin tone as super light.She denied having any abnormal skin conditions.The patient had not previously used other heat products for pain relief (electric heating pad, hot water bottle or microwave gel pack).She did not engage in exercise while using the product.The patient did read the usage instructions prior to using the heatwrap.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included aloe and gauze.Clinical outcome of the events was not resolved.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 on stomach, the size of her first finger in length, wrap had eaten through stomach; took skin completely off, and sleeping while wearing product as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event of heatwrap to numb stomach pain from uti is assessed as non-serious and associated with the use of the device., comment: based on the information provided, the events of burns on stomach, the size of her first finger in length, wrap had eaten through stomach; took skin completely off, and sleeping while wearing product as described in this case are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the use of the device.The event of heatwrap to numb stomach pain from uti is assessed as non-serious and 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 assmt.& rationale: a lot trend was not performed as the lot number is unknown.Site sample status was not received.

Event Description

Event verbatim [preferred term].Burns on stomach, the size of her first finger in length [thermal burn], wrap had eaten through stomach; took skin completely off [skin exfoliation], using heatwrap to numb stomach pain from uti/the patient did read the usage instructions prior to using the heatwrap [intentional device use issue].Narrative: this is a spontaneous report from a contactable consumer.A 45-year-old female patient started to use thermacare heatwrap (thermacare lower back & hip) 8 hr from (b)(6) 2016 to numb stomach pain from urinary tract infection (uti).Medical history included ongoing graves disease, urinary tract infection (uti) and ongoing sensitive skin.Concomitant medication included ongoing thiamazole (methimazole) for graves' disease and ciprofloxacin (cipro) tablet from (b)(6) 2016 for uti.Past product history included thermacare heatwraps (thermacare heatwraps) from an unspecified date for an unspecified indication with no adverse effect.On (b)(6) 2016, the patient reported she applied the heatwrap around her waist and back before going to bed to numb her stomach pain from her uti.On (b)(6) 2016, the patient reported she awoke in the middle of the night, around 3:17 am, and her stomach was on fire and when she actually woke up at 4:45 am she noticed the wrap had eaten through her stomach, took the skin completely off.She did not know the level of degree of burns to her stomach but described the burns as the size of her first finger in length.She stated she wore the heatwrap over a t shirt and light lace underwear.The patient mentioned she was sleeping while wearing product and used the product for a total of 4 hours.She had not consulted a healthcare professional, she stated she was on her way to see an hcp at the time of the report.The patient assessed her skin tone as super light.She denied having any abnormal skin conditions.The patient had not previously used other heat products for pain relief (electric heating pad, hot water bottle or microwave gel pack).She did not engage in exercise while using the product.The patient did read the usage instructions prior to using the heatwrap.Action taken with the suspect product was permanently withdrawn on (b)(6) 2016.Therapeutic measures taken included aloe and gauze.The outcome of the events "burns on stomach, the size of her first finger in length" and "wrap had eaten through stomach; took skin completely off" was not resolved, of the other event was unknown.According to the product quality complaint group: 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.No follow up attempts possible.No further information is expected.Follow-up (24feb2017): follow-up attempts are completed.No further information is expected.Follow-up (14apr2020): new information received from a product quality complaints group includes: investigation results.No follow up attempts possible.No further information is expected.

• 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: 6108889
• MDR Text Key: 60095201
• Report Number: 1066015-2016-00148
• 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: 11/08/2016

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?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CIPRO; CIPRO [DOSAGE FORM:] TABLET; METHIMAZOLE; METHIMAZOLE [DOSAGE FORM:]; CIPRO; METHIMAZOLE
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 88