MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR L/XL 2CT; HOT OR COLD DISPOSABLE PACK.

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Ulcer (2274); Blister (4537)

Event Date 07/11/2022

Event Type  Injury  

Event Description

On 11-jul-2022, a spontaneous report from the united states was received via telephone regarding a 71-year-old female who used a thermacare lower back & hip l/xl heat wrap.Medical history included atrial fibrillation, asthma, hypertension, cancer, and sciatic pain.Concomitant products included eliquis (apixaban), proair (albuterol sulfate inhaler), candesartan, vitamin d, and unspecified supplements.On (b)(6) 2022, the consumer applied a thermacare lower back & hip l/xl heat wrap over her bathing suite to her lower back.On (b)(6) 2022, the morning after using the product while she was at the beach for 8 hours, she had two red dots, a burning sensation, and an open blister at the application site.The consumer noted that she was not in the water with the product and that it might have rolled up while she had it on, but she was not certain.The consumer thought that the two red dots and burning sensation were due to a burn.The area was so painful she could not touch it.She contacted a pharmacist who advised her to apply aloe vera gel, not wrap it, and keep the aloe in the refrigerator for added comfort.No additional information was provided.

Manufacturer Narrative

The root cause cannot be identified.There is limited device specific information provided, no batch number was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation 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 blisters and other skin irritations.The manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure packaged product quality.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR L/XL 2CT
• 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 ; 4237178579
• MDR Report Key: 15140631
• MDR Text Key: 296998891
• Report Number: 3007593958-2022-00051
• 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: Other
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 07/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CANDESARTAN; ELIQUIS (APIXABAN); PROAIR (ALBUTEROL SULFATE INHALER); UNSPECIFIED SUPPLEMENTS; VITAMIN D
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female