MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE LOWER BACK & HIP; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0581

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Bridges consumer healthcare received the following spontaneous report from angelini italy on 12-jan-2024.Angelini italy received the report on 01-jan-2024.The report verbatim is as follows: this serious spontaneous case, manufacturer control number 2024-033152 is an initial report from germany received on 01/jan/2024 from a consumer/other non-health professional through diamed (de3581).This case report concerns a 51-years-old male patient, who applied thermacare lower back and hip( batch number ga0581 and expiry date jun-2025) for unknown indication.Concomitant medication(s):unknown.Medical history: burn ointment to treat the adverse event.On an unknown date after thermacare lower back and hip initiation, the patient experienced burns second degree.The indication for use was unknown.After wearing the thermacare heat wraps for approximately 6 hours directly on the skin, the consumer experienced pain from a burn and had to remove the heat wrap.The consumer experienced second degree burns at the application site.The burn was treated with a burn ointment.Outcome: burns second degree : unknown the action taken in response for the event thermacare lower back and hip was unknown.The anticipated date of the next report is 20-feb-2024.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.

Manufacturer Narrative

On 24-jan-2024, angelini s.P.A.Provided bridges consumer healthcare additional information.Angelini s.P.A.Received the additional information on 12-jan-2024.The verbatim of the information is as follows: follow-up information received on 12/01/2024 from qa department.Complaint number (b)(4); batch #: ga0581; batch code/sku#: f00573301023w; product count: (b)(4) ; date of manufacture: 25-jul-2022 to 26-jul-2022; expiry date: 06-30-2025; quantity released: (b)(4).A 36-month trend analysis has been conducted.The trend analysis returned a total of (b)(4) complaints for lower back and hip 8 hour products during the period (b)(6) 2021 to (b)(6)2024 for the class/subclass none of the complaints were confirmed to have a manufacturing process root cause for a complaint of adverse event safety request for investigation.Based on this trend analysis, the data did not show an increase over time.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare lower back and hip 8 hour product.There is no further action required.Considering the current information available for this complaint it is not possible to determine a root cause.However, there are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).There are mitigations in place to prevent these situations such as in-process testing, thermal testing and visual inspections to ensure the quality and safety of the product.There are also 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.Our 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.All materials used in the production of this batch were inspected and released by quality control before being released for use.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.There are pre-identified risk factors that could cause burns listed in the hazard analysis (rpt-000097160).During the investigation of this complaint rpt-000097160 was reviewed and no further risk was identified.Since this complaint is not justified and there is no identified defect, there is no change needed to the risk documentation as a result of this investigation.Based on the information provided, the event of burns second degree as described in this case is 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 pi of thermacare lower back and hip mentions that burns second degree could be an adverse event of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse event-medical device is plausible.Based on the information provided, the causal relationship between thermacare lower back and hip and the reported adverse event was considered as possible.Parent batch ga0581 is the only batch within the scope of this investigation.The device history record, manufacturing electronic system records, retain samples, thermal results, raw materials and trending were evaluated.No quality issues were identified during the production of the batch.No retain evaluation is required for this complaint, as no defect was reported.Visual inspection of the product would not be beneficial as a consumer experiencing a burn can't be detected by reviewing the wrap.The batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in processing inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.There were no wrap attribute or variable defects recorded for the batch.The most probable root cause cannot be identified.A 36-month trend analysis has been conducted.The data did not show an increase over time.There is not a trend identified for the subclass.There is no further action required.

• Brand Name: THERMACARE LOWER BACK & HIP
• 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 Key: 18520268
• MDR Text Key: 332947078
• Report Number: 3007593958-2024-00001
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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 Number: GA0581
• Initial Date Manufacturer Received: 01/01/2024
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/24/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male