MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK AND HIP 8CT + NSW 1CT; HOT OR COLD DISPOSABLE PACK.

Lot Number GA00155

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Pain (1994); Peeling (1999); Skin Tears (2516); Partial thickness (Second Degree) Burn (2694)

Event Date 10/30/2022

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be identified.There was limited device-specific information provided, no batch number or return sample available for evaluation.Without a batch reference number, a manufacturing and technical assessment cannot be completed for the wrap involved in this case.No product quality-related trend was identified for the subclass adverse event safety request for investigation.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid the risk of burns.The manufacturing operations employ quality control procedures, including process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.

Event Description

On 31-oct-2022, a spontaneous report from the united states was received via email regarding a 68-year-old female consumer who used thermacare lower back & hip 8hr.Medical history included hypertension, seasonal allergies, and drug allergies to cefzil (cefprozil) and "sulfa" sulfonamides.The consumer reported that she had been using thermacare heat wraps for an unspecified number of years and loved them.Concomitant products included losartan, metoprolol, and other unspecified medications that the consumer declined to provide.On (b)(6) 2022, she applied a thermacare lower back & hip 8ct l/xl to her low back/hip area directly on her skin even though the label indicates to use a clothing barrier if above the age of 55.She noted she was recently burned.It was clarified that she left the heat wrap on for approximately nine to ten hours despite label instructions not to use longer than eight hours in a 24-hour period.When she later removed the wrap, she stated that the skin came off with the wrap which prompted her to look at the area.She noticed redness and skin peeling which she assumed was a deroofed blister.She reported that the area was painful and bled for a short amount of time.At the time of reporting, all symptoms are ongoing except for the bleeding.The consumer reported that no medical care had been sought and that she had been applying neosporin to the affected area.She denied the presence any signs or symptoms of infection.On 03-nov-2022 during a follow-up telephone call to the consumer, she noted that the pain had abated and that although there was some mild redness and peeling of the skin still present, the area was healing was healing.Consumer stated that she had not been evaluated by a medical provider as recommended.No further information was received after 03-nov-2022.

• Brand Name: THERMACARE LOWER BACK AND HIP 8CT + NSW 1CT
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4234142221
• MDR Report Key: 15858566
• MDR Text Key: 304279596
• Report Number: 3007593958-2022-00078
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Lot Number: GA00155
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOSARTAN.; METOPROLOL.; UNSPECIFIED MEDICATIONS.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female