MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE TTHERMACARE LOWER BACK & HIP 8HR; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0379

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Superficial (First Degree) Burn (2685); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

On 05-dec-2023, bridges consumer healthcare received a spontaneous report from angelini s.P.A.Angelini s.P.A.Received the report on 24-nov-2023.This serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 24/nov/2023 from a consumer/other non-health professional through diamed (de3440).This case report concerns a 66-years-old male patient , who applied thermacare lower back and hip ( batch lot: ga0379 and expiry date mar/2025) for intervertebral disc prolapse,sciatic neuralgia.Concomitant medication(s):wound plasters medical history: unknown.On unknown date after thermacare lower back and hip initiation, the patient experienced administration site stinging, thermal burn, wound oozing.The patient experienced a stabbing pain and a burn, when using the third patch of the pack.The burn had roughly the size of one cell and was on the spot of only one of the cells.The wound wept and the patient treated it by himself with wound plasters, changing them every day for 14 days.After that time, the scar was still visible.The consumer had used thermacare occasionally for years, but never experienced complaints as described above.Further information was not available at the time of this report.Outcome: administration site stinging : unknown, thermal burn : unknown, wound oozing : unknown.The action taken in response for the event to thermacare lower back and hip was unknown.Angelini medical assessment: the pi of thermacare lower back and hip mentions that administration site stinging, thermal burn and the related wound oozing could be adverse events of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare lower back and hip and the reported adverse events was considered as possible.The overall assessment for this case is serious/labeled/possible.The anticipated date of the next report: 12-jan-2024.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.

Manufacturer Narrative

On 20-dec-2023 angelini s.P.A.Provided bridges consumer healthcare additional information regarding the case.Angelini s.P.A.Received the information on 13-dec-2023.Follow up was received on 13/dec/2023 from qa department.Complaint number (b)(4).Batch #: ga0379.Batch code/sku#: f00573301009w.Product count: 4 count.Date of manufacture: 15-apr-2022 to 21-apr-2022.Expiry date: 03-31-2025.Quantity released: (b)(4) cartons.A 36-month trend analysis has been conducted.The trend analysis returned a total of 130 complaints for lower back/hip (lbh) heat wrap 8 hr products during the period 11-24-2020 to 11-24-2023 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 hip 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.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.This complaint complies with the requirements stated in investigation procedure wi-000098885 processing consumer complaints, effective 21-sep-2022 and it is recommended for approval.The audit trail review is positive per wi-000087714 trackwise digital complaints, version 3.0, effective 23-aug-2023.There are pre-identified risk factors that could cause a burn 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 events of administration site stinging, thermal burn and the related wound oozing 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 administration site stinging, thermal burn and the related wound oozing could be adverse events of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare lower back and hip and the reported adverse events was considered as possible.The overall assessment for this case is serious/labeled/possible.Batch ga0379 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.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects to carton or pouched wraps.The complaint was evaluated to identify a potential trend for the lot and subclass.A trend does not exist for this batch.Review of 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.Considering the current information available for this complaint it is not possible to determine a root cause.No quality issues were identified upon the 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.

Event Description

On 08-jan-2024, angelini s.P.A.Provided additional information to bridges consumer healthcare regarding the case.Angelini s.P.A.Received the information on 20-dec-2023.The information is provided below: follow-up information was received on 20-dec-2023 regarding the application and outcome.The male consumer applied the heat wrap directly onto the skin, as he had previously always done.The burn was caused by one individual heat cell.The scar is still easily visible.A photograph was provided.Outcome: administration site stinging: recovered/resolved with sequelae, thermal burn: recovered/resolved with sequelae, wound oozing: recovered/resolved with sequelae, intentional device misuse: recovered/resolved with sequelae.Based on the information provided, the events of administration site stinging, thermal burn and the related wound oozing 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 intentional device misuse.The pi of thermacare lower back and hip mentions that administration site stinging, thermal burn and the related wound oozing could be adverse events of this medical device, whereas it does not mention intentional device misuse.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare lower back and hip and the reported adverse events was considered as possible, for intentional device misuse it was considered not assessable.The overall assessment for this case is serious/unlabeled/possible angelini medical assessment: the information provided in this fu does change the previous assessment.Pi of thermacare lower back and hip does not mention that intentional device misuse could be an adverse event of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare lower back and hip and the added reported adverse event was considered as not assessable, for the other events possible.The overall assessment for this case is serious/unlabeled/possible.

• Brand Name: TTHERMACARE LOWER BACK & HIP 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 Key: 18348311
• MDR Text Key: 330817142
• Report Number: 3007593958-2023-00078
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• 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,Followup
• Report Date: 01/09/2024

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 Expiration Date: 03/01/2023
• Device Lot Number: GA0379
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 12/13/2023; 12/20/2023
• Supplement Dates FDA Received: 12/27/2023; 01/10/2024
• 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: 66 YR
• Patient Sex: Male