FDA Adverse Event Injury Summary report: N

SMARTXIDE2

MDR report key: 11984978 · Received June 11, 2021

Report

Report Number: 1222993-2021-00018
Event Type: Injury
Date Received: June 11, 2021
Date of Event: May 11, 2021
Report Date: June 11, 2021
Manufacturer: EL. EN. ELECTRONIC ENGINEERING SPA
Product Code: GEX
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A CT OF PELVIS WITH RECTAL CONTRAST WAS PERFORMED AND NO ABNORMALITY OR PERFORATION WAS FOUND. SPECULUM EXAM REVEALED THAT THERE WAS A SMALL SUPERFICIAL TEAR IN THE VAGINAL MUCOSA, NOT INVOLVING THE PERITONEUM. A GI TRACK, LIVER, DIAPHRAGM, SPLEEN, AND A PELVISCOPY EXAM WAS CONFIRMED TO BE ALL NORMAL. GAS WAS OBSERVED IN THE OMENTUM. PATIENT WAS PLACED ON IV ANTIBIOTICS AND WAS OBSERVED FOR 3 DAYS. PATIENT WAS RELEASED HOME ON NASAL O2 TO TREAT PNEUMOTHORAX. THIS INCIDENT IS DETERMINED TO BE INCONCLUSIVE. A RECENT DEVICE EVALUATION FOUND THE UNIT OPERATING AS INTENDED AND WORKING WITHIN SPECIFICATION. THIS EVENT IS REPORTABLE BECAUSE THE PATIENT RECEIVED MEDICAL INTERVENTION AND DIAGNOSED WITH PNEUMOTHORAX. HOWEVER, THE ROOT CAUSE IS INCONCLUSIVE BECAUSE THERE WAS NO CONFIRMATION THAT IT WAS RELATED TO TREATMENT AND DEVICE WAS FOUND TO BE OPERATING WITHIN SPECIFICATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT EXPERIENCED VAGINAL BLEEDING, ABDOMINAL PAIN, BLOATING, AND CHEST PRESSURE FOLLOWING A MONALISA TOUCH TREATMENT USING SMARTXIDE2. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED AND PATIENT WAS TAKEN TO THE ER AND WAS SEEN BY AN ER PHYSICIAN. A CHEST X-RAY WAS PERFORMED AND SHOWED SMALL PNEUMOTHORAX AND AIR IN HER NECK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
881726	SMARTXIDE2	SMARTXIDE2	GEX	EL. EN. ELECTRONIC ENGINEERING SPA

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR		Required Intervention