MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for CYNOSURE CELLULAZE - SLT II 105-0056-810 manufactured by El. En. Electronic Engineering Spa.
[135333631]
It was made aware that a patient death occurred following a laser treatment on the thighs area. This claim was made by the patient's brother who indicated that the death was due to bleeding. However, the customer site stated the patient's laser treatment had proceeded normally and her blood pressure was in good standing. The customer site stated that the patient did not show up for any follow up checkups. Prior to the laser treatment, it was disclosed that the patient was currently taking antidepressant medications. Patient was also given alprazolam orally for sedation and lidocaine/epinephrine for tumescent anesthesia as part of the pre-treatment activities. There was no additional information provided by the customer site regarding the patient's death or treatment procedure. The device was evaluated and found to be operated as intended within specification. One of the expected side effects from an slt ii laser procedure is bleeding, but due to limited information available, a relationship between the patient's death and procedure could not be determined from this investigation. This is a reportable event due to a patient death.
Patient Sequence No: 1, Text Type: N, H10
[135333632]
A patient had died following a laser procedure with the slt ii device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2019-00003 |
| MDR Report Key | 8313178 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-04-19 |
| Date Facility Aware | 2019-01-17 |
| Report Date | 2019-02-06 |
| Date Reported to FDA | 2019-02-06 |
| Date Reported to Mfgr | 2019-02-01 |
| Date Added to Maude | 2019-02-06 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYNOSURE CELLULAZE - SLT II |
| Generic Name | ND: YAG LASER |
| Product Code | OYW |
| Date Received | 2019-02-06 |
| Catalog Number | 105-0056-810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EL. EN. ELECTRONIC ENGINEERING SPA |
| Manufacturer Address | VIA BALDANZESE 17 CALENZANO, ITALY 50041 IT 50041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-02-06 |