MAUDE Adverse Event Report: ULTRATONE SCIENTIFIC INSTRUMENTS, LTD FUTURA PRO; NONE

Model Number USFPC1

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Pain (1994); Complaint, Ill-Defined (2331); Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Date 05/07/2014

Event Type  Injury  

Event Description

(b)(6) 2014, around 8pm cst: futura pro demo performed by u.S.Sales rep (b)(4) on physician/pt at his home; 15 minutes of abdominal/flank area ultrasound cavitation using conduction gel; followed by 8 tens unit pads placed on skin in abdominal/flank area x 40 minutes.Treatment with intensity initially controlled by sales rep then turned over to physician/pt; sales rep performing demo indicated the futura pro was completely safe.No informed consent forms or contraindications were discussed.Sales rep conducted demonstration on physician/pt to promote sale of unit for (b)(4) usd for use in his cosmetic surgery practice for "off label" use since the 510k was not yet approved for "weight loss in pts in u.S." for either the muscle stimulator or the ultrasound portions.(b)(6) (evening) until (b)(6) physician/patient experienced daily symptoms of progressive abdominal fullness, distension, vague digestion, and early satiety following minimal food intake.(b)(6) around 7pm cst: abdominal fullness, distension, and pain began to intensify with complete cessation of flatus, nausea experienced by physician/pt.(b)(6) around 3am cst: physician/pt experienced full spectrum of symptoms for a complete bowel obstruction and presented himself to hospital for evaluation in the ed.(b)(6) at hospital: eval of physician/pt revealed a complete bowel obstruction on 64-slice ct scan with iv contrast.No masses or tumors were detected.Ngt placed to low intermittent wall suction.General surgery and hospitalist consultations were done.Npo status with iv pain meds and complete bowel rest were implemented.(b)(6) at hospital: finally, after 3 episodes of flatus the ng tube was removed thereby allowing an upper gi barium swallow study with small bowel follow through to be done with barium contrast showing a completely normal study.(b)(6): physician/pt was discharged from hospital to home with resolution of complete small bowel obstruction.On hospital discharge summary, all three consulting general and trauma surgeons caring for this physician/pt referenced a probable link to a (b)(6) medical device demo.One of the surgeons stated "possible paralytic segment of bowel from recent tens.".

• Brand Name: FUTURA PRO
• Type of Device: NONE
• Manufacturer (Section D): ULTRATONE SCIENTIFIC INSTRUMENTS, LTD; ashford, kent TN23 6LN
• MDR Report Key: 3932746
• MDR Text Key: 4579938
• Report Number: MW5037228
• Device Sequence Number: 1
• Product Code: IMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: USFPC1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 75