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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE LOWER BACK & HIP L/XL 8HR; HOT OR COLD DISPOSABLE PACK.
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BRIDGES CONSUMER HEALTHCARE THERMACARE LOWER BACK & HIP L/XL 8HR; HOT OR COLD DISPOSABLE PACK. Back to Search Results
Lot Number GA0600
Device Problem Insufficient Information (3190)
Patient Problems Itching Sensation (1943); Pain (1994); Partial thickness (Second Degree) Burn (2694)
Event Date 07/04/2023
Event Type  Injury  
Manufacturer Narrative
The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports " suffered burns".The cause of the consumer stating "suffered burns" is inconclusive since review of records does not provide evidence to support defective product.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).In addition to these hazards, there are multiple risks that are outside the control of the site.These include things like age, skin condition, medical conditions, device use error and off-label use.The warning labels on our product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.This is an adverse event for a burn and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
 
Event Description
This spontaneous report was received from a 59-year-old, nonsmoking female consumer via telephone regarding her simultaneous use of a thermacare lower back and hip heat wrap and a thermacare menstrual 8 hr heat wrap (please refer to case number (b)(4).).On 24-jul-2023, additional information was received from a consumer.On 04-jul-2023, the consumer topically applied a thermacare menstrual 8 hr heat wrap directly to her abdomen and a thermacare lower back and hip heat wrap to her lower back over her shirt.She applied the wraps to treat pain related to lumbar damage she sustained during a fall that occurred in (b)(6) 2022.She left the wraps in place for eight hours and reported that she suffered burns on both her back and abdomen upon removing the wraps.The consumer reported that the burn on her back was almost gone and that she had no associated pain.She stated that the burn on her abdomen was pink with some "exposed skin" and that it measured approximately two centimeters.She reported that it was not weeping and that she had been cleansing it with normal saline, applying neosporin topically and covering it with sterile gauze daily.On (b)(6) 2023 it was learned that the burn on her back was healed however the burn on her lower abdomen became worse.She was admitted to the hospital for 3 days starting on (b)(6) 2023 due to a combination of her burn and her historical heart failure.Her burn was painful and had oozing blisters.She was treated for 3 days with an unspecified intravenous (iv) antibiotic, a milrinone drip, and 80 mg of lasix (furosemide) iv push for 2 days and only once on the third day for her heart failure.Her wound still was very itchy, and she anticipated seeing her doctor on (b)(6) 2023.The reporter provided information regarding the related thermacare menstrual 8hr heat wrap case ((b)(4).).
 
Event Description
On (b)(6) 2024, it was reported that consumer used the thermacare products for 6 hours.She could feel it getting hot but did not have any pain medications and she kept them on.She checked the areas and saw small burn marks.She tried to treat it herself, but the menstrual area became infected and was tender to the touch.She went to an emergency room.She had shortness of breath and chest pain, so she was admitted to the hospital.She had blood tests which showed she was infected with "mansonella ozzardi" (not clinically verified).She was given 3 iv doses of clindamycin and sent home with augmentin (amoxicillin and clavulanic acid).The abdominal wound was covered with gel colloidal bandages.She had several black marks on her mid and left lower quadrant which remained tender.No additional information was provided.
 
Manufacturer Narrative
The site investigated this complaint by reviewing the device history records and manufacturing controls.The review of the device history records, batch thermal records, and production controls met the product release criteria.Consumer reports " suffered burns".The cause of the consumer stating "suffered burns" is inconclusive since review of records does not provide evidence to support defective product.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).In addition to these hazards, there are multiple risks that are outside the control of the site.These include things like age, skin condition, medical conditions, device use error and off-label use.The warning labels on our product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.This is an adverse event for a burn and a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.
 
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Brand Name
THERMACARE LOWER BACK & HIP L/XL 8HR
Type of Device
HOT OR COLD DISPOSABLE PACK.
Manufacturer (Section D)
BRIDGES CONSUMER HEALTHCARE
811 broad street, suite 600
chattanooga TN 37402
Manufacturer (Section G)
ANGELINI
1231 wyandotte dr
albany GA 31705
Manufacturer Contact
rebecca ethridge
1231 wyandotte dr
albany, GA 31705
2294463085
MDR Report Key17465650
MDR Text Key320471860
Report Number3007593958-2023-00044
Device Sequence Number1
Product Code IMD
UDI-Device Identifier00305733010396
UDI-Public305733010396
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/06/2024
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 Lot NumberGA0600
Initial Date Manufacturer Received 07/12/2023
Initial Date FDA Received08/04/2023
Supplement Dates Manufacturer Received02/15/2024
Supplement Dates FDA Received03/08/2024
Date Device Manufactured06/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
"MANY" OTHER UNSPECIFIED MEDICATIONS.; INSULIN.; METOPROLOL.
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient SexFemale
Patient Weight163 KG
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