MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK AND HIP 8 HR HEAT WRAP; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0056

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

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

Event Type  Injury  

Event Description

On (b)(6) 2022, bridges consumer healthcare received the thermacare case from angelini s.P.A.Which received the case on (b)(6) 2022.The report verbatim is as follows: this serious spontaneous case, manufacturer control number 2022-029303 is an initial report from (b)(6) received on (b)(6) 2022 from a consumer/other non-health professional through diamed (de2345).This case report concerns a 65-years-old male patient, who applied thermacare flexible use (batch number 56) for 5 hours for tightness of back muscles, on unknown date.Concomitant medications and medical history were not reported.On unknown date, after thermacare flexible use initiation, the patient developed burn blister.After 5 hours of application, he experienced burn blisters in the area of the "nubs" of the lowest row of the heat wrap.Exactly where the nubs had been positioned, 4 burn blisters developed.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The anticipated date of the next report is (b)(6) 2023.

Event Description

On (b)(6) 2022, bridges consumer healthcare received the thermacare case from angelini s.P.A.Which received the case on (b)(6) 2022.The report verbatim is as follows: this serious spontaneous case, manufacturer control number 2022-029303 is an initial report from germany received on (b)(6) 2022 from a consumer/other non-health professional through diamed (de2345).This case report concerns a 65-years-old male patient, who applied thermacare flexible use (batch number 56) for 5 hours for tightness of back muscles, on unknown date.Concomitant medications and medical history were not reported.On unknown date, after thermacare flexible use initiation, the patient developed burn blister.After 5 hours of application, he experienced burn blisters in the area of the "nubs" of the lowest row of the heat wrap.Exactly where the nubs had been positioned, 4 burn blisters developed.Outcome: burn blister : unknown.The action taken in response to the events was unknown.

Manufacturer Narrative

On 09-mar-2023, bridges consumer healthcare received additional information from angelini s.P.A who received the information on 05-may-2023.The report verbatim is as follows: follow-up received on 05-may-2023 from qa department (cn-089513).Batch #: ga0056.Batch code/sku#: f00573301009w.Product count: 4 count.Date of manufacture: 17-jul-2021 to 22-jul-2021.Expiry date: 2024-06-30.Quantity released: (b)(4) cartons.Batch ga0056 is the only batch within the scope of this investigation.Thermacare batches are produced as individuals lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.After a review of the batch records, all results met product release criteria.Consumer reports "a burn after use", but the investigation is inconclusive since review of records does not provide evidence to support defective product.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 no defects have been identified.Data analysis was performed taking the period from 12-07-2019 to 12-07-2022 for the subclass adverse event safety request for investigation which includes burns for thermacare lbh products.The search returned a total of 96 complaints for lbh products during this period for the class/subclass.Based on this search, the data did not show an increase over time.There is not a trend identified 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.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.This complaint is not justified and the occurrence rate is low.There is no change needed to the risk documentation as a result of this investigation.Based on the information provided, the event of burn blister 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.In accordance with instructions for use (ifu) of thermacare approved in june 2022 by the notified body (nb) issuing the mdr certification, that states in the section "special warnings and precautions for use" that the product can cause burns/blisters, angelini will consider events of burns (of any grade) as expected effects; therefore, pi of thermacare lower back and hip mentions that burn blister could be an adverse event of this medical device.Temporal association adverse event-medical device is plausible.Based on the information provided the causal relationship between thermacare lower back and hip and incident is considered as possible batch ga0056 is the only batch within the scope of this investigation.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.The visual inspection of a retain sample included one carton and the four pouched wraps inside, and shows no obvious defects to carton or pouched wraps.An evaluation of the complaint history confirms that this is the second complaint for the sub-class adverse event safety request for investigation received and requiring an evaluation of this batch.The complaint was evaluated to identify any potential trend.A trend was not identified.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attribute and variable quality checks associated with this batch indicate that all required in process inspections were performed and all inspection criteria were met.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.

• Brand Name: THERMACARE LOWER BACK AND HIP 8 HR HEAT WRAP
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr.; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4234142221
• MDR Report Key: 16035451
• MDR Text Key: 306013530
• Report Number: 3007593958-2022-00095
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: GA0056
• Date Manufacturer Received: 05/09/2023
• 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: 65 YR
• Patient Sex: Male