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

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

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 03/07/2024

Event Type  Injury  

Event Description

This serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 08/mar/2024 from a consumer/other non-health professional through diamed (de3911).This case report concerns a female patient (age: unknown), who applied thermacare heat wraps (batch number: unknown; expiry date: unknown) for product used for unknown indication.Concomitant medication(s): unknown.Medical history included: unknown.On (b)(6) 2024, after thermacare heat wraps initiation, the patient experienced burns second degree, thermal burn.The consumer applied thermacare heat wraps, but the heat wrap slipped whilst wearing it and the consumer experienced burns with two blisters on her stomach.Outcome: burns second degree: unknown, thermal burn : unknown the action taken in response to the event for thermacare heat wraps was unknown.Angelini medical assessment: the pi of thermacare heat wraps mentions that burns second degree and thermal burn 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 heat wraps 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 is 26-apr-2024.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.

Manufacturer Narrative

On 05-apr-2024, angelini s.P.A.Provided bridges consumer healthcare additional information.Angelini s.P.A.Received the information on 25-mar-2024.Information received on 25-mar-2024 form qa department.Complaint number: (b)(4).The complaint complies with the requirements stated in investigation procedure (b)(4).Processing consumer complaints, effective 02-jan-2024 and it is recommended for approval.Due to the fact that this complaint was received for an unknown product type and no lot information available, there is not enough data available to conduct trending.Should more data become available, the complaint will be reopened, and trending will be completed, if possible.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.Processing consumer complaints, effective 02-jan-2024 and it is recommended for approval.Due to the fact that this complaint was received for an unknown product type and no lot information available, there is not enough data available to conduct trending.Should more data become available, the complaint will be reopened and trending will be completed, if possible.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.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 event of burns second degree and 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 mentions that burns second degree and thermal burn 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 heat wraps and the reported adverse events was considered as possible.This investigation was conducted for an unknown batch number of thermacare product.There was limited device specific information provided.No product type or 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.Due to the fact that this complaint was received for an unknown product type and no lot information is available, there is not enough data available to conduct trending.Should more data become available, the complaint will be reopened, and trending will be completed, if possible.Considering the current information available for this complaint it is not possible to determine a root cause.

• 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; chjattanooga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; albany, GA 31075 ; 2294463085
• MDR Report Key: 18989118
• MDR Text Key: 338737174
• Report Number: 3007593958-2024-00017
• 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
• Report Date: 03/21/2024

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: 03/21/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/09/2024
• 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 Sex: Female