MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-12 for ACCENT XL manufactured by Alma Lasers Ltd.
[89259468]
(b)(4). Please note that for system device with serial (b)(4), the approximate age of device as required in the report is 13 months. The device manufacture date for this system as required in the report is 09/01/2017. This information could not be entered in their respective fields due to software limitation. Alma lasers investigated the reported event and attempted follow-ups on patient's condition. In the recent follow up, it was reported that patient's tinnitus has worsened and she is experiencing increased hearing loss in her affected ear. Devices (system and handpiece) were evaluated by alma lasers inc. (importer). They were found to be within manufacturing specs and did not contribute to the adverse event. At this point, alma lasers cannot determine if the patient's hearing has worsened due to the procedure or has been decreasing successively every year due to the history of pre-existing condition. In all good faith efforts alma lasers is reporting this incident to the fda. Also, chief scientist officer at alma lasers ltd researched the history of the ultrasound handpiece by reaching out to the experts using this device worldwide and found no similar events i. E. Worsening of tinnitus. This is a singular incident, however, alma lasers will evaluate any future similar events for a meaningful trend. If a trend emerges, alma lasers will take necessary action at that time. Should any additional information becomes available, alma lasers ltd will file a follow-up report within time lines published by fda.
Patient Sequence No: 1, Text Type: N, H10
[89259469]
The suspected device was used at the facility on a staff member (hereafter, designated as the patient for this event). This device was used on her arms with the rf procedure and after that ultrasound was used. Patient allegedly reported that following the procedure her pre-existing tinnitus worsened in the left ear. She stated that right after the ultrasound procedure, her left ear had an "underwater" sound and her tinnitus "doubled in the intensity". The intensity has not decreased since the treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004167969-2017-00001 |
| MDR Report Key | 6945929 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-08-23 |
| Date Facility Aware | 2017-09-14 |
| Date Mfgr Received | 2017-09-19 |
| Device Manufacturer Date | 2017-02-19 |
| Date Added to Maude | 2017-10-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. ARIELA ALBALAK |
| Manufacturer Street | 14 & 15 HALAMISH ST. POB 3021 CAESAREA NORTH INDUSTRIAL PARK |
| Manufacturer City | CAESAREA, HA ZAFON 3088900 |
| Manufacturer Country | IS |
| Manufacturer Postal | 3088900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCENT XL |
| Generic Name | ULTRASONIC DIATHERMY |
| Product Code | IMI |
| Date Received | 2017-10-12 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALMA LASERS LTD |
| Manufacturer Address | 14 & 15 HALAMISH ST. POB 3021 CAESAREA NORTH INDUSTRIAL PARK CAESAREA, HA ZAFON 3088900 IS 3088900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-12 |