MAUDE Adverse Event Report: MIBO MEDICAL GROUP MIBO THERMOFLO; PAD, HEATING, POWERED

Health Effect - Clinical Codes	Dry Eye(s) (1814); Unspecified Infection (1930); Discomfort (2330); Eye Pain (4467)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Severe dry eye and ongoing eye pain after receiving mibo thermoflo treatment in (b)(6) 2019.Reporter states that this procedure "burnt my eye." reporter states that this device was used on the meibomian gland to alleviate dry eye symptoms.She has suffered from dry eyes for many years, and after performing internet searches, learned of mibo thermoflo and found a provider who performed this treatment in her area.She states the device is supposed to heat up to "108 degrees" and is applied over the eye, targeting the meibomian gland.Reporter was scheduled for four rounds of treatment but stopped going after three sessions due to pain and discomfort.She also told the provider "i don't feel good" however these concerns were dismissed and was instead encouraged to continue with treatment.Shortly after the procedure, she developed an infection in her right eye, which "had never happened to me before" and now "my eye is a million times worse" because "all the moisture was sucked out of my eye." she describes it "felt like an iron was placed on my eye" and that due to ongoing pain and dry eye symptoms that this experience has been "my worst nightmare." reporter states that her dry eye is so bad that when she cries, she produces no tears.

• Brand Name: MIBO THERMOFLO
• Common Device Name: PAD, HEATING, POWERED
• Manufacturer (Section D): MIBO MEDICAL GROUP
• MDR Report Key: 15094950
• Report Number: MW5111092
• Device Sequence Number: 19241252
• Product Code: IRT
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female