MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-02-08 for CYNOSURE CELLULAZE - SLT II M094E1 manufactured by El.en. Electronic Engineering S.p.a..
[135511339]
The actual device was not returned to the manufacturer for evaluation. Us importer's authorized service personnel checked the actual device unit at customer site on january 31st, 2019. The technician found, prior to any servicing operation, the device to be working properly within specifications ((b)(4)). The us importer have performed various attempts to contact the physician that performed the treatment to the patient but did not receive any response. Anyway, they contacted (b)(6) owner, ms. (b)(6) that disclosed details relative to the patient condition before and after the procedure. The site's owner stated that the patient was under antidepressant before the procedure. The patient's data collected before and during the procedure, relative to the blood pressure and oxygen saturation, were fine and are the following: pre-op blood pressure: 130/91, pulse: 86, pulse ox: 96; during treatment, pulse ranged from 75-87, pulse ox ranged from 97-95. Patient was given 1 mg of. 5mg alprazolam orally for sedation. 3 bags of 50cc 2% lidocaine with 1cc epinephrine was administered for tumescent anesthesia. Surgery start was at 9:30 am and ended at 1:30pm. Used ace bandages post and no compression wear following the procedure. The total amount of energy delivered to the patient for each area are the following: outer right thigh-10264 total joules; inner right thigh- 6835 total joules; outer left thigh- 6500 total joules; inner left thigh- 7199 total joules. The site owner disclosed the information related to the date of the treatment that was performed on (b)(6) 2018 at (b)(6), us and performed by dr. (b)(6). Moreover they stated that the patient never show up for follow-up visits after the procedure. (b)(4), us importer of the slt ii laser medical device, performed their investigation and found on the web the obituary that performed the funeral services of the patient ((b)(6) funeral & cremation services). Based on the information gathered there the date of birth of the patient and her death date were obtained (dob: (b)(6), dod: (b)(6) 2018). These information are in contradiction with what stated by the patient's brother that reported, in his initial communication of the event, that the patient died 4 days ater the treatment. In fact, based on the information gathered during the investigation, and stated above, the patient's death happened 18 days after the treatment. Despite the numerous attempts performed by the us importer to contact both the initial reporter and the site, in order to obtain any additional information, they did not receive any response. That said it is not possible to evaluate if the patient's death, caused by bleeding, is in any matter related with the device. Anyway, the bleeding is a known side effect for the treatment with the slt ii laser medical device as reported in the operator's manual code om094e1_g. V09 at chapter 'cellulaze adverse effects'. The investigation carried out did not conclude that a design deficiency or device malfunctioning was responsible for causing the event. With the limited information available, we are unable to determine a conclusion for this event. Device working within specifications. No remedial action required in case of new information will be made available for this case a follow-up to this report will be submitted in a timely manner. This initial report is to be considered as final report, unless fda has further questions.
Patient Sequence No: 1, Text Type: N, H10
[135511340]
On january 21st, 2019, el. En. Electronic engineering (b)(4) became aware of an adverse event, reported by us importer, (b)(4), that received a communication from the brother of the patient, concerning the death of the patient 4 days after a treatment with slt ii laser medical device. The patient's brother reported to the us importer, on january the 17th, 2019, that her sister has died due to bleeding following a treatment with the slt ii laser medical device on the thighs area. We, the manufacturer of the device, requested the cooperation of our us importer (b)(4) located in (b)(4) us, for the investigation on this case. (b)(4), at the time of the initial communication to us already took charge of the complaint and immediately started its own investigation. (b)(4) also represents us distributor and service center for el. En. Electronic engineering (b)(4) medical devices. (b)(4) identified the actual device involved in the event as an slt ii laser medical device serial number #(b)(4), ref #m094e1 manufactured by el. En. Electronic engineering (b)(4) company placed in (b)(4). The actual involved medical device is installed at (b)(6). (b)(4)'s clinical staff performed the investigation by contacting several times the site but the physician who performed the treatment dr. (b)(6) without any response. (b)(4), then, contacted the owner of the site (b)(6) in order to obtain information regarding the patient's condition and the treatment. Ms. (b)(6) stated, regarding patient conditions, that the patient only disclosed being on antidepressant. Moreover ms. (b)(6) stated that the treatment 'was smooth, no extra bleeding, blood pressure was good'. (b)(4) company located in (b)(4) us submitted an mdr initial report to fda for this event (#1222993-2019-00003) on february the 6th, 2019. We, the manufacturer of device, became aware of the event on january the 21st, 2019 by email from the us importer and, according to 21 cfr part 803. 50(b)(2), submitted to fda an own mdr report in order to conduct an investigation of the event and to obtain missing or incomplete information provided by the importer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001431138-2019-00002 |
| MDR Report Key | 8319889 |
| Report Source | OTHER |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-08 |
| Date of Event | 2018-04-19 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2017-05-15 |
| Date Added to Maude | 2019-02-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ANDREA CHECCHI |
| Manufacturer Street | VIA BALDANZESE 17 |
| Manufacturer City | CALENZANO, FIRENZE 50041 |
| Manufacturer Country | IT |
| Manufacturer Postal | 50041 |
| Manufacturer G1 | EL.EN. ELECTRONIC ENGINEERING S.P.A. |
| Manufacturer Street | VIA BALDANZESE 17 |
| Manufacturer City | CALENZANO, FIRENZE 50041 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 50041 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYNOSURE CELLULAZE - SLT II |
| Generic Name | CYNOSURE CELLULAZE - SLT II |
| Product Code | OYW |
| Date Received | 2019-02-08 |
| Model Number | M094E1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EL.EN. ELECTRONIC ENGINEERING S.P.A. |
| Manufacturer Address | VIA BALDANZESE 17 CALENZANO, FIRENZE 50041 IT 50041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-02-08 |