MAUDE Adverse Event Report: ALMA LASERS LTD. FEMILIFT LASER TREATMENT; POWERED LASER SURGICAL INSTRUMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Numbness (2415); Full thickness (Third Degree) Burn (2696)

Event Date 03/01/2021

Event Type  Injury  

Event Description

The patient called to report an adverse event from the femilift laser treatment she had done on (b)(6) 2021.Patient stated she does not believe the physician used the device correctly and says she has been suffering since the treatment in (b)(6).Patient stated she has scars on her vaginal wall and 3rd degree burns inside her vaginal wall and labia and numbness of the anterior wall of her vagina.Patient stated she has constant burning and pain and has been unable to have intercourse since the treatment.Patient stated this has severely impacted her life, and when she kept going back to see the doctor explaining she was in severe pain, the doctor just kept telling her she was healing fine.Patient stated that no doctors know what do to or how to help her because they have never seen this type of issue before.Patient stated she has no idea what to do now, and that she's very unhappy with the treating physician and believes he did not use the device correctly on her.Patient stated during the treatment she was telling the physician that it was very painful, but they kept going anyway.

• Brand Name: FEMILIFT LASER TREATMENT
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ALMA LASERS LTD.
• MDR Report Key: 12122299
• MDR Text Key: 260073633
• Report Number: MW5102303
• Device Sequence Number: 1
• Product Code: GEX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/06/2021

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR