MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE MENSTRUAL 8HR 3+1CT; HOT OR COLD DISPOSABLE PACK.

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Itching Sensation (1943); Pain (1994); Partial thickness (Second Degree) Burn (2694); Skin Infection (4544)

Event Date 07/04/2023

Event Type  Injury  

Event Description

This spontaneous report was received from a 59-year-old, nonsmoking female consumer via telephone regarding her simultaneous use of a thermacare menstrual 8 hr heat wrap and a thermacare lower back and hip heat wrap (please refer to case number (b)(4) ).On 24-jul-2023, additional information was received from a consumer.On (b)(6) 2023, the consumer topically applied a thermacare menstrual 8 hr heat wrap directly to her lower 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 lower back and hip heat wrap case ( (b)(4) ).

Manufacturer Narrative

The root cause and root cause sub class cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a 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 investigation.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for a burn of the product.A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Manufacturer Narrative

The root cause and root cause sub class cannot be identified.There was limited device-specific information provided, no batch number or return sample was available for evaluation.Without a batch reference number or a 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 operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event for a burn and a risk calculation cannot be determined as there is no known batch number to identify if there were a device malfunction.

Event Description

On 15-feb-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 (her lower back as well) 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.

• Brand Name: THERMACARE MENSTRUAL 8HR 3+1CT
• 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 PHARMA; 1231 wyandotte dr; GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; 4234142221
• MDR Report Key: 17471473
• MDR Text Key: 320592317
• Report Number: 3007593958-2023-00045
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• 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,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
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/11/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "MANY" OTHER UNSPECIFIED MEDICATIONS; INSULIN; METOPROLOL
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 163 KG