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

Lot Number GA0670

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

Angelini s.P.A.Provided the following case information to bridges consumer healthcare on 20-feb-2024.Angelini s.P.A.Received the information on 12-feb-2024.The report verbatim is as follows: this serious spontaneous case, manufacturer control number 2024-033545 is an initial report from germany received on 12/feb/2024 from a pharmacist through diamed (de3772).This case report concerns a 78-years-old female patient , who applied thermacare lower back and hip (batch number: ga0670) for unknown indication.Concomitant medication(s): [unknown].Medical history: past use of thermacare heat wraps.On an unknown date after thermacare lower back and hip initiation, the patient experienced burn, intentional device misuse.78 year-old female consumer suffered from minor burns in three places after using thermacare.The consumer applied the heat wraps directly onto the skin during the day, not whilst sleeping.On 09/feb/2024 the consumer had crusts on the wounds and assumed that even wearing a thin layer of clothing would not have prevented the incident.The consumer had previous experience with thermacare without problems.This time most of the belt's honeycombs felt smooth, but some had a very uneven surface.Further information was not available at the time of this report.Outcome: burn : unknown, intentional device misuse : unknown.The action taken in response for the events to thermacare lower back and hip was unknown.Angelini medical assessment: the pi of thermacare lower back and hip mentions that burn could be an adverse event 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 event was considered as possible, for intentional device misuse it was considered not assessable.The overall assessment for this case is serious/unlabeled/possible.The anticipated date of the next report is 29-mar-2024.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.

Manufacturer Narrative

Angelini s.P.A.Provided additional information about the report on 18-mar-2024 to bridges consumer healthcare.Angelini s.P.A.Received the information on 06-mar-2024.The report verbatim is as follows: follow up received from angelini qa ((b)(4)) on 06/mar/2024: this complaint complies with the requirements stated in investigation procedure (b)(4) processing consumer complaints, effective (b)(6) 2024 and it is recommended for approval.A 36-month trend analysis has been conducted.The trend analysis returned a total of 126 complaints for lower back and hip 8 hour products during the period 02-09-2021 to 02-09-2024 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.The ppm for this complaint is 1.72 ppm; which is within the control limit for this subclass and product type.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare lbh 8hr products.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.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 burn 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 burn could be an adverse event 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 event was considered as possible, for intentional device misuse it was considered not assessable.Batch ga0670 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.A visual inspection of the product would not be beneficial as a consumer experiencing a burn can't be detected by reviewing the wrap.The complaint was evaluated to identify a potential trend for the batch and subclass.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare lbh 8hr products.There is no further action required.The evaluation of the batch history shows this is the first complaint for the subclass adverse event safety request for investigation.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 process inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.Considering the current information available for this complaint it is not possible to determine a root cause.This complaint is not justified and no issues were found during batch/production data review to suggest the adverse event was related to a product defect.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks.The product is within expiration date.The product quality for the batch is not impacted by this complaint.

Event Description

Angelini s.P.A.Provided the following case information to bridges consumer healthcare on 20-feb-2024.Angelini s.P.A.Received the information on 09-feb-2024.Angelini s.P.A.Provided bridges consumer healthcare additional information on 19-mar-2024 which has been incorporated into the report below.The report verbatim is as follows: this serious spontaneous case, manufacturer control number 2024-033545 is an initial report from germany received on 09/feb/2024 from a pharmacist through diamed (de3772).This case report concerns a 78-years-old female patient , who applied thermacare lower back and hip (batch number: ga0670) for unknown indication.Concomitant medication(s): [unknown].Medical history: past use of thermacare heat wraps.On an unknown date after thermacare lower back and hip initiation, the patient experienced burn, intentional device misuse.78 year-old female consumer suffered from minor burns in three places after using thermacare.The consumer applied the heat wraps directly onto the skin during the day, not whilst sleeping.On 09/feb/2024 the consumer had crusts on the wounds and assumed that even wearing a thin layer of clothing would not have prevented the incident.The consumer had previous experience with thermacare without problems.This time most of the belt's honeycombs felt smooth, but some had a very uneven surface.Further information was not available at the time of this report.Outcome: burn : unknown, intentional device misuse : unknown.The action taken in response for the events to thermacare lower back and hip was unknown.Angelini medical assessment: the pi of thermacare lower back and hip mentions that burn could be an adverse event 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 event was considered as possible, for intentional device misuse it was considered not assessable.The overall assessment for this case is serious/unlabeled/possible.

• 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 ; 2294463092
• MDR Report Key: 18817365
• MDR Text Key: 336731998
• Report Number: 3007593958-2024-00013
• 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,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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 Lot Number: GA0670
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/20/2024
• 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: 78 YR
• Patient Sex: Female