MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE HEATWRAP; HOT OR COLD DISPOSABLE PACK

Lot Number GA0377P

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 07/29/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on (b)(6) 2023 from a consumer/other non health professional through diamed (de3061).This case report concerns a female patient (70+ years), who applied thermacare heat wraps (batch number ga0377p, expiry date: unknown) for pain back, from (b)(6) 2023 to (b)(6) 2023.Concomitant medications were not reported.Medical history included: fractured coccyx.On (b)(6) 2023, 1days after thermacare heat wraps initiation, the patient experienced burn blister, intentional device misuse.During an additional phone call on (b)(6) 2023 the elderly female consumer (70+ years) stated that she had used the product for several years already.Her medical history included a broken coccyx in her childhood, which occasionally causes lower back pain and therefore she uses thermacare heat wraps regularly.So far she had only positive experiences with the thermacare product.On (b)(6) 2023 she had applied the heat wrap at approx.7 p.M.Directly on her skin.She usually applies the heat wrap directly on the skin in order to get pain relief.She went to bed and removed the heat wrap approx.At 10 a.M.On (b)(6) 2023.After the removal she noticed two burn blisters (size of 1-cent coin) and one larger one (size of 2-cent coin) on her back, which were extremely painful.She had already used two heat wraps of the same box, without any issues.Outcome: burn blister : unknown, intentional device misuse : unknown.The action taken in response to the events for thermacare heat wraps was unknown.Angelini medical assessment: the pi of thermacare heat wraps mentions that burn blister could be adverse event of this medical device, whereas it does not mention intentional device misuse.Dechallenge and rechallenge were not applicable.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare heat wraps and the event is considered as possible, for intentional device misuse it was considered not assessable.The overall assessment for this case is serious/unlabeled/possible.

Manufacturer Narrative

On 23-aug-2023, angelini s.P.A.Provided bridges consumer healthcare additional information regarding the report.Angelini s.P.A.Received the information on 10-aug-2023.The report verbatim is as follows: follow up received on 10/08/2023 from qa department.Complaint numbercn-(b)(4).A 36-month trend analysis has been conducted for subclass adverse event safety request investigation complaints including known and unknown lot numbers.The records search returned a total of 12 complaints for the flexible use xl products during this time period, for the subclass for all adverse events (including burns).There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation.Based on this search, 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 flexible use xl.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.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 intentional device misuse.The pi of thermacare heat wraps (thermacare flexible use 8 hour) mentions that burn blister could be adverse event of this medical device, whereas it does not mention intentional device misuse.Temporal association adverse event-medical device is plausible.Based on the information provided, the causal relationship between thermacareheat wraps (thermacare flexible use 8 hour) and the event is considered as possible, for intentional device misuse it was considered not assessable.Parent batch ga0377 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.A retain evaluation was performed.The visual inspection of a retain sample included six (6) pouched wraps and shows no obvious defects to 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 requiring an evaluation of 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 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.There were no wrap attribute defects or variable defects recorded for the batch.The complaint was evaluated to identify a potential trend for the lot and subclass: a trend does not exist for this lot.The most probable root cause cannot be identified.

• Brand Name: THERMACARE HEATWRAP
• 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 ; 2294463088
• MDR Report Key: 17550243
• MDR Text Key: 321226329
• Report Number: 3007593958-2023-00048
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 05733010396
• UDI-Public: 05733010396
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

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 Lot Number: GA0377P
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/25/2023
• 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: 70 YR
• Patient Sex: Female