MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-08 for ACCENT RF manufactured by Alma Lasers Ltd.
[138272514]
(b)(4). (b)(4) (importer) has made an attempt for device retrieval and is in the process of making further attempts to request the device back for evaluation. Alma ltd. Clinical reached out to an independent medical expert for the medical assessment. As per their assessment, the patient may have had deep second degree burns. (b)(4) has made multiple attempts to request patient follow-up condition; no updates are available. Alma ltd. Clinical has therefore, determined this event to be reportable and is submitting this report to the fda in good faith efforts. Should any information become available, alma will submit supplemental report within the fda published timelines.
Patient Sequence No: 1, Text Type: N, H10
[138272515]
The suspected device was used on the patient's abdomen. As per the facility, the patient reported she has sustained a small burn 1 inch to the right of her belly button. The patient called in to report this burn two weeks after the treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004167969-2019-00009 |
| MDR Report Key | 8404853 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-08 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-01-22 |
| Date Facility Aware | 2019-02-06 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2018-07-17 |
| Date Added to Maude | 2019-03-08 |
| 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 | AVI HIRSHNZON |
| Manufacturer Street | 14 & 15 HALAMISH ST. POB 3021 CAESAREA NORTH INDUSTRIAL PARK |
| Manufacturer City | CAESAREA HAZAFON 3088900, |
| Manufacturer Country | IS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCENT |
| Generic Name | MEDICAL LASER |
| Product Code | IMI |
| Date Received | 2019-03-08 |
| Model Number | RF |
| Device Availability | N |
| 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 HAZAFON 3088900, IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-03-08 |