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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

Angelini s.P.A.Provided bridges consumer healthcare with the following report on 17-jan-2024.Angelini s.P.A.Received the report on 08-jan-2024.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from austria received on 08/jan/2024 from a consumer/other non-health professional through angelini austria (pqc229).This case report concerns a 34-years-old male patient , who took thermacare heat wraps for lower back (batch number unknown but requested for unknown indication.Concomitant medication(s):unknown.Medical history: unknown.On an unknown date, for approximately 7 hours, after thermacare heat wraps for lower back initiation, the patient experienced thermal burn.The consumer reported that he applied thermacare approximately 7 hours and experienced burns on his lower back.One week later, at the time of the report, the skin has not recovered yet, according to the consumer.According to the consumer, the batch number cannot be retrieved, since the whole packaging was thrown out outcome: thermal burn : not recovered/not resolved the action taken in response for event to thermacare lower back and hip was unknown.Angelini medical assessment: the pi of thermacare heat wraps for lower back mentions that thermal burn 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 heat wraps for lower back and the reported adverse event was considered as possible.The overall assessment for this case is serious/labeled/possible.The anticipated date of the next report is 27-feb-2024.

Manufacturer Narrative

On 20-feb-2024, angelini s.P.A.Provided bridges consumer healthcare additional information.Angelini s.P.A.Received the information on 13-feb-2024.The information verbatim is as follows: follow up received on 13/feb/2024 from qa, complaint number (b)(4): this investigation was conducted for an unknown batch of lbh product.There was 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.A 36-month trend analysis has been conducted, the records search returned a total of 126 complaints for lbh products during this time period.The search described in this investigation summary takes into consideration all adverse events.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare lbh 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 burns 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.This complaint complies with the requirements stated in investigation procedure (b)(4) processing consumer complaints, effective 02-jan-2024 and it is recommended for approval.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 thermal 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 use of the device.The pi of thermacare heat wraps for lower back mentions that thermal burn 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 heat wraps for lower back and the reported adverse event was considered as possible.This investigation was conducted for an unknown batch number of lbh product with the sub class adverse event safety request for investigation.There was limited device specific information provided.Without a valid batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.The complaint was evaluated to identify any potential trends.A 36-month trend analysis will be conducted for complaints with an unknown batch number since the date of manufacture is unknown for unknown batch numbers.There is not a trend identified.There is no further action required.The most probable root cause cannot be identified.

• Brand Name: THERMACARE LOWER BACK AND 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: 18547788
• MDR Text Key: 333315363
• Report Number: 3007593958-2024-00002
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/21/2024

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: 01/08/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/22/2024
• 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: 34 YR
• Patient Sex: Male