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

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the incident is in progress.Investigation methods or the ability to conduct an investigation is currently being determined.Additional information will be provided.

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via email.The report regarded an unspecified thermacare lower back and hip heat wrap.On an unspecified date, when the consumer opened up the package, she discovered the heat wraps were leaking.

Manufacturer Narrative

Evaluation of the incident is in progress.Investigation methods or the ability to conduct an investigation is currently being determined.Additional information will be provided.Evaluation of the incident is in progress.Investigation methods or the ability to conduct an investigation is currently being determined.Additional information will be provided.Additional information received from angelini on 20-jul-2022.The root cause cannot be identified.There was limited device-specific information provided, the batch number was not available.Without a batch reference number, or a returned sample for evaluation a manufacturing and technical assessment cannot be completed for the wrap involved in this case.No product quality-related trend was identified for the subclass heat cell damaged/leaking.The manufacturing operations employ quality control procedures, including process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.

Event Description

On 20-jun-2022, a spontaneous report from the united states was recieved via email.The report regarded an unspecified thermacare lower back and hip heat wrap.On an unspecified date, when the consumer opened up the package, she discovered the heat wraps were leaking.At the time of the report no further information was provided.

• Brand Name: THERMACARE LOWER BACK & HIP
• 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 ; 4237178579
• MDR Report Key: 15057796
• MDR Text Key: 302852501
• Report Number: 3007593958-2022-00048
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female