inforMED
MalfunctionQAJ

INNOVO, TYPE NUMBER 208

Received Aug 3, 2023 · Event occurred Mar 15, 2022

Report 3015223097-2023-00012 · MDR key 17451750

Device

Generic name

Cutaneous Electrode Stimulator For Urinary Incontinence

Model number

208

Catalog number

0208-5007

Lot number

20191223

Product problems

  • Stretched
  • Stretched

Patient

55 YR · Female

  • Dizziness
  • Insufficient Information
  • Dizziness
  • Insufficient Information

Narrative

Description of Event or Problem

FINAL REPORT SUBMITTED WITH NO ADDITIONAL INFORMATION. RETROSPECTIVE REVIEW OF SIMILAR EVENTS - NO PATIENT INJURY OR HARM COMPLAINT NUMBER: (B)(4) WAS REPORTED IN THE US ON THE 15TH MARCH 2022 WITH AN IRREGULAR HEART BEAT, LIGHT HEADEDNESS AND FEELING "WEIRD" WHILE USING THE DEVICE. NO REPORTED LONG TERM HEALTH OR INJURY. NO REPORTED DEVICE DEFECT. CUSTOMER CONTACTED THEIR PHYSICIAN WHO ADVISED THEM TO CEASE USE OF THE DEVICE. THE INNOVO DEVICE WAS RETURNED ON THE 23RD MAY 2022 AND INSPECTED FOR DEFECTS. THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED WITH TEARS EVIDENT ON VISUAL INSPECTION.

Description of Event or Problem

RETROSPECTIVE REVIEW OF SIMILAR EVENTS - NO PATIENT INJURY OR HARM. COMPLAINT NUMBER: (B)(4) WAS REPORTED IN THE US ON THE 15TH MARCH 2022 WITH AN IRREGULAR HEART BEAT, LIGHT HEADEDNESS AND FEELING "WEIRD" WHILE USING THE DEVICE. NO REPORTED LONG TERM HALTH OR INJURY. NO REPORTED DEVICE DEFECT. CUSTOMER CONTACTED THEIR PHYSICIAN WHO ADVISED THEM TO CEASE USE OF THE DEVICE. THE INNOVO DEVICE WAS RETURNED ON THE 23RD MAY 2022 AND INSPECTED FOR DEFECTS. THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED WITH TEARS EVIDENT ON VISUAL INSPECTION.